Clinical trial • Phase III • Oncology

TINENGOTINIB for Cholangiocarcinoma

Phase III trial of TINENGOTINIB for Cholangiocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Cholangiocarcinoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-10-2023
First CTIS Authorization Date
27-02-2024

Trial design

Randomised, open-label, physician's choice: treatment per physician's choice including chemotherapy agents/regimens (comparator agents listed include oxaliplatin, irinotecan, 5‑fluorouracil, folinic acid; regimens may include combination chemotherapy such as folfox or folfiri as per physician choice).-controlled Phase III trial in Germany, Spain, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician's Choice: treatment per physician's choice including chemotherapy agents/regimens (comparator agents listed include Oxaliplatin, Irinotecan, 5‑Fluorouracil, Folinic acid; regimens may include combination chemotherapy such as FOLFOX or FOLFIRI as per physician choice).
Biomarker Stratified
True, FGFR2 fusion/rearrangement
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
105
Trial Duration For Participant
280

Eligibility

Recruits 105 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be able to understand and sign the informed consent form (ICF); consent is provided by the participant (adults ≥18). No assent or proxy consent for minors is described (study enrolment restricted to ≥18 years)..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be able to understand and sign the informed consent form (ICF); consent is provided by the participant (adults ≥18). No assent or proxy consent for minors is described (study enrolment restricted to ≥18 years).

Inclusion criteria

  • {"criterion_text":"- 1.\t≥ 18 years of age at the time of signing the informed consent form (ICF).\n- 9. Must agree to take sufficient contraceptive measures to avoid pregnancy (including male and female subjects) during the study and for at least 3 months after the end of treatment (EOT) for subjects randomized to the tinengotinib arm, and for at least 6 months after the EOT for subjects randomized to Physician’s Choice arm. (Note: for subjects who receive oxaliplatin to be at least 9 months for women of child-bearing potential and 6 months for men; for subjects who receive irinotecan to be at least 6 months for women of child-bearing potential and 3 months for men). Subjects will be considered to be of childbearing potential unless surgically sterile with a hysterectomy and/or bilateral oophorectomy or ≥ 12 months of amenorrhea.\n- 11. Life expectancy≥12 weeks.\n- 10.\tAble to understand and sign the ICF and comply with the protocol.\n- 2.\tHistologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.\n- 3.\tDocumentation of presence FGFR2 fusion/rearrangement gene status\n- 4.\tSubjects must have received at least one line of prior chemotherapy and exactly one FGFR inhibitor.\n- 5.\tRadiographically measurable disease per RECIST v1.1, as confirmed by central imagining review (BICR). •\tAt least one target lesion of ≥ 10 mm in the longest diameter for a non lymph node or ≥ 15 mm in the short-axis diameter for a lymph node using computed tomography (CT)/magnetic resonance imaging (MRI). If there is only one target lesion and it is a non-lymph node, it should have the longest diameter of ≥ 15 mm. •\tA target lesion must not be chosen from a previously irradiated area, unless it is a new lesion that appeared after completion of radiotherapy or show evidence of disease progression after completion of radiotherapy based on RECIST v1.1.\n- 6.\tMust agree to blood collection for liquid biopsy genomic testing.\n- 7.\tEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n- 8.\tAdequate organ function as evidenced by: •\tAbsolute neutrophil count ≥ 1.5 × 109/L •\tHemoglobin ≥ 9 g/dL •\tPlatelet count ≥ 75 × 109/L •\tAspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN if liver metastases are present •\tTotal bilirubin ≤ 1.5 × ULN; or < 2.5 × ULN if Gilbert syndrome or disease involving liver •\tCreatinine clearance >30 mL/min (Cockcroft Gault formula) •\tAdequate blood coagulation function as evidence by an international normalized ratio (INR) ≤ 1.5 unless subject is on anticoagulants"}

Exclusion criteria

  • {"criterion_text":"- 1.\tPrior receipt of two or more FGFR inhibitors, either approved or investigational drugs."}
  • {"criterion_text":"- 10.\tSubjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic despite adequate treatment with antihypertensive medications at screening)."}
  • {"criterion_text":"- 2. Prior receipt of both FOLFOX and FOLFIRI chemotherapy regimens."}
  • {"criterion_text":"- 20. Subjects who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma including chemotherapy) from adverse events (AEs) of prior therapy."}
  • {"criterion_text":"- 11.\tSubjects with a fistula, impairment of gastrointestinal function, or gastrointestinal disease that may significantly alter the absorption, metabolism, or excretion of tinengotinib."}
  • {"criterion_text":"- 3.\tSubjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases, no adequate treatment with radiotherapy, symptomatic, requiring treatment with anticonvulsants). Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment."}
  • {"criterion_text":"- 4.\tSubjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy."}
  • {"criterion_text":"- 5.\tSubjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug."}
  • {"criterion_text":"- 6.\tConcurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval."}
  • {"criterion_text":"- 7.\tSubjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy."}
  • {"criterion_text":"- 8.\tSubjects who have undergone major surgery ≤ 4 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy."}
  • {"criterion_text":"- 9.\tImpaired cardiac function or significant diseases, including but not limited to any of the following: •\tHistory of congestive heart failure with New York Heart Association (NYHA) Class III or IV. •\tHistory of risk factors for Torsades de Pointes (TdP) including hypokalemia, or congenital long QT syndrome, or familial history of prolonged QT syndrome, etc. •\tQT interval with Fredericia’s correction (QTcF) ≥ 480 msec on screening electrocardiogram (ECG) (If QTcF measurement is not available, please consult with the cardiologist to exclude the risk of TdP). •\tUnstable angina pectoris ≤ 3 months prior to starting study drug. •\tAcute myocardial infarction or stroke ≤ 6 months prior to starting study drug. •\tCardiac arrhythmia that is unstable requiring antiarrhythmic medical treatment (rate control medication, i.e. beta blockers, are permitted). Subjects with a pacemaker or well-controlled rhythm for at least 1 month prior to the first dose will be allowed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part A •\tIncidence, duration, and severity of adverse events (AEs), as assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).","definition_or_measurement_approach":"Assessed per CTCAE v5.0 (or the most current version): incidence, duration and severity of AEs."}
  • {"endpoint_text":"- Part B •\tProgression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.","definition_or_measurement_approach":"PFS defined as time from randomization to first documented progression per BICR using RECIST v1.1, or death from any cause, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Part A •\tORR，DOR by Investigator","definition_or_measurement_approach":"Objective response rate (ORR) and duration of response (DOR) assessed by investigator (definitions per RECIST v1.1 where applicable)."}
  • {"endpoint_text":"- •\tPK analysis","definition_or_measurement_approach":"Pharmacokinetic (PK) analysis of tinengotinib (including population PK analyses)."}
  • {"endpoint_text":"- Part B •\tOverall survival (OS): OS is defined as the time from date of randomization to date of death of any cause.","definition_or_measurement_approach":"OS defined as time from randomization to death from any cause."}
  • {"endpoint_text":"- •\tObjective Response Rate (ORR) by BICR and by Investigator: ORR is defined as the proportion of subjects with a best overall response of complete response (CR) or partial response (PR), as assessed by BICR and by the investigator, per RECIST v1.1.","definition_or_measurement_approach":"ORR per RECIST v1.1 as assessed by BICR and investigator (CR or PR as best overall response)."}
  • {"endpoint_text":"- •\tDuration of Response (DOR) by BICR and by Investigator: DOR is defined as the time from date of first documented CR or PR to the date of first documented progressive disease (PD) or death due to any cause by BICR and by investigator’s assessment per RECIST v1.1.","definition_or_measurement_approach":"DOR = time from first documented CR/PR to first documented PD or death, per BICR and investigator using RECIST v1.1."}
  • {"endpoint_text":"- •\tPFS by Investigators per RECIST v1.1.","definition_or_measurement_approach":"PFS assessed by investigators per RECIST v1.1."}
  • {"endpoint_text":"- •\tIncidence, duration, and severity of AEs: as assessed per CTCAE v5.0 (or the most current version).","definition_or_measurement_approach":"Assessed per CTCAE v5.0 (or most current version): incidence, duration, severity of AEs."}
  • {"endpoint_text":"- •\tEuropean Organization for the Research and Treatment of Cancer Quality of Life Questionnaire: global HRQOL, functioning (physical) and symptoms (fatigue); and EORTC QLQ-BIL21 in tinengotinib vs. Physician’s Choice.","definition_or_measurement_approach":"Health-related quality of life measured by EORTC QLQ-C30 domains (global HRQOL, physical functioning, fatigue) and EORTC QLQ-BIL21 comparisons between arms."}
  • {"endpoint_text":"- •\tPopulation PK: for the tinengotinib arm.","definition_or_measurement_approach":"Population pharmacokinetic (PK) analysis in treated and PK-evaluable subjects in the tinengotinib arm."}

Recruitment

Planned Sample Size
105
Recruitment Window Months
37
Consent Approach
Informed consent must be provided by the participant (participants must be ≥18 and able to understand and sign the informed consent form). Subject information and ICF documents are available in multiple languages as evidenced by uploaded SIS/ICF documents (English, Spanish, French, German, Italian, Polish, Portuguese, Dutch and country-specific versions). No assent process for minors is described (study restricted to adults).

Geography

Total Number Of Sites
43
Total Number Of Participants
95

Germany

Earliest CTIS Part Ii Submission Date
08-02-2024
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
690
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Principal Investigator Name
Volker Heinemann
Principal Investigator Email
Volker.Heinemann@med.uni-muenchen.de
Contact Person Name
Volker Heinemann
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut fuer Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Goetze
Principal Investigator Email
Goetze.Thorsten@KHNW.DE
Contact Person Name
Thorsten Goetze
Contact Person Email
Goetze.Thorsten@KHNW.DE
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Tumorzentrum Hamburg, Abteilung fuer Onkologie
Principal Investigator Name
Dirk Arnold
Principal Investigator Email
d.arnold@asklepios.com
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum fuer Tumorerkrankungen (NCT), Abteilung Medizinische Onkologie
Principal Investigator Name
Christoph Springfeld
Principal Investigator Email
christoph.springfeld@med.uni-heidelberg.de
Contact Person Name
Christoph Springfeld
Site Name
Kreiskliniken Reutlingen GmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Stefan Kubicka
Principal Investigator Email
kubicka_s@klin-rt.de
Contact Person Name
Stefan Kubicka
Contact Person Email
kubicka_s@klin-rt.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik fuer Gastroenterologie, Infektiologie, Hepatologie und Endokrinologie
Principal Investigator Name
Anna Saborowski
Principal Investigator Email
saborowski.anna@mh-hannover.de
Contact Person Name
Anna Saborowski
Contact Person Email
saborowski.anna@mh-hannover.de

Spain

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
692
Number Of Sites
12
Number Of Participants
22

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Principal Investigator Name
Angela Lamarca Lete
Principal Investigator Email
angela.lamarca@quironsalud.es
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Medical Oncology
Principal Investigator Name
Roberto Antonio Pazo Cid
Principal Investigator Email
rpazo@salud.aragon.es
Contact Person Name
Roberto Antonio Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Principal Investigator Name
Alejandro Forner Gonzalez
Principal Investigator Email
aforner@clinic.cat
Contact Person Name
Alejandro Forner Gonzalez
Contact Person Email
aforner@clinic.cat
Site Name
Clinica Universidad De Navarra
Department Name
Medical Oncology
Principal Investigator Name
Mariano Ponz Sarvise
Principal Investigator Email
mponz@unav.es
Contact Person Name
Mariano Ponz Sarvise
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Carmen Guillen Ponce
Principal Investigator Email
carmenguillenponce@gmail.com
Contact Person Name
Carmen Guillen Ponce
Contact Person Email
carmenguillenponce@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Jorge Adeva Alfonso
Principal Investigator Email
jorge.adeva@salud.madrid.org
Contact Person Name
Jorge Adeva Alfonso
Contact Person Email
jorge.adeva@salud.madrid.org
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology
Principal Investigator Name
Elena Maria Brozos Vazquez
Principal Investigator Email
elena.maria.brozos.vazquez@sergas.es
Contact Person Name
Elena Maria Brozos Vazquez
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical Oncology
Principal Investigator Name
Rafael Alvarez Gallego
Principal Investigator Email
ralvarezgallego@hmhospitales.com
Contact Person Name
Rafael Alvarez Gallego
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Medical Oncology
Principal Investigator Name
Mariano Ponz Sarvise
Principal Investigator Email
mponz@unav.es
Contact Person Name
Mariano Ponz Sarvise
Contact Person Email
mponz@unav.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Principal Investigator Name
Andres Jesus Munoz Martin
Principal Investigator Email
andresmunmar@hotmail.com
Contact Person Name
Andres Jesus Munoz Martin
Contact Person Email
andresmunmar@hotmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Medical Oncology
Principal Investigator Name
Rosa Maria Rodriguez Alonso
Principal Investigator Email
rosarodriguezalonso@gmail.com
Contact Person Name
Rosa Maria Rodriguez Alonso
Contact Person Email
rosarodriguezalonso@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Alejandro Garcia Alvarez
Principal Investigator Email
agalvarez@vhio.net
Contact Person Name
Alejandro Garcia Alvarez
Contact Person Email
agalvarez@vhio.net

France

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
725
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Clinique De La Sauvegarde
Department Name
Oncologie médicale
Principal Investigator Name
Yann Molin
Principal Investigator Email
dryannmolin@gmail.com
Contact Person Name
Yann Molin
Contact Person Email
dryannmolin@gmail.com
Site Name
Hopital Beaujon
Department Name
Liver Cancer Unit and Therapeutic Innovation
Principal Investigator Name
Mohamed Bouattour
Principal Investigator Email
mohamed.bouattour@aphp.fr
Contact Person Name
Mohamed Bouattour
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Cancerology
Principal Investigator Name
Laurent Mineur
Principal Investigator Email
l.mineur@isc84.org
Contact Person Name
Laurent Mineur
Contact Person Email
l.mineur@isc84.org
Site Name
IHFB Cognacq Jay
Department Name
Department of Medical Oncology
Principal Investigator Name
Benoist Chibaudel
Principal Investigator Email
benoist.chibaudel@cognacq-jay.fr
Contact Person Name
Benoist Chibaudel
Site Name
Hopital Saint Antoine
Department Name
Hepatology Department
Principal Investigator Name
Violaine Ozenne
Principal Investigator Email
Violaine.ozenne@aphp.fr
Contact Person Name
Violaine Ozenne
Contact Person Email
Violaine.ozenne@aphp.fr
Site Name
Besancon University Hospital Center
Department Name
Medical Oncology
Principal Investigator Name
Angélique Vienot
Principal Investigator Email
A3vienot@chu-besancon.fr
Contact Person Name
Angélique Vienot
Contact Person Email
A3vienot@chu-besancon.fr
Site Name
Institut Gustave Roussy
Department Name
Medical oncology
Principal Investigator Name
Antoine Hollebecque
Principal Investigator Email
antoine.hollebecque@gustaveroussy.fr
Contact Person Name
Antoine Hollebecque

Belgium

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
717
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology
Principal Investigator Name
Karen Geboes
Principal Investigator Email
Karen.geboes@uzgent.be
Contact Person Name
Karen Geboes
Contact Person Email
Karen.geboes@uzgent.be
Site Name
UZ Leuven
Department Name
Digestive Oncology
Principal Investigator Name
Jeroen Dekervel
Principal Investigator Email
Jeroen.dekervel@uzleuven.be
Contact Person Name
Jeroen Dekervel
Contact Person Email
Jeroen.dekervel@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Timon Vandamme
Principal Investigator Email
timon.vandamme@uza.be
Contact Person Name
Timon Vandamme
Contact Person Email
timon.vandamme@uza.be

Poland

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
689
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Lucjan Wyrwicz
Principal Investigator Email
lucjan.wyrwicz@nio.gov.pl
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl

Portugal

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
30-12-2025
Processing Time Days
697
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Oncologia
Principal Investigator Name
Gonçalo Costa
Principal Investigator Email
g.nogueiradacosta@gmail.com
Contact Person Name
Gonçalo Costa
Contact Person Email
g.nogueiradacosta@gmail.com
Site Name
Champalimaud Clinical Centre
Department Name
Unidade de Digestivos
Principal Investigator Name
Nuno Couto
Principal Investigator Email
nuno.couto@fundacaochampalimaud.pt
Contact Person Name
Nuno Couto

Austria

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
709
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Internal Medicine I; Division of Medical Oncology and Haematology
Principal Investigator Name
Bernhard Doleschal
Principal Investigator Email
bernhard.doleschal@ordensklinikum.at
Contact Person Name
Bernhard Doleschal
Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Division of Internal Medicine, Haematology and Internal Oncology
Principal Investigator Name
Birgit Grünberger
Principal Investigator Email
Birgit.Gruenberger@wienerneustadt.lknoe.at
Contact Person Name
Birgit Grünberger

Italy

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
707
Number Of Sites
10
Number Of Participants
24

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Oncologia Falck
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
salvatore.siena@ospedaleniguarda.it
Contact Person Name
Salvatore Siena
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica Gastroenterologia
Principal Investigator Name
Monica Niger
Principal Investigator Email
monica.niger@istitutotumori.mi.it
Contact Person Name
Monica Niger
Site Name
Humanitas Research Hospital
Department Name
Oncologia Medica e Ematologia
Principal Investigator Name
Lorenza Rimassa
Principal Investigator Email
lorenza.rimassa@hunimed.eu
Contact Person Name
Lorenza Rimassa
Contact Person Email
lorenza.rimassa@hunimed.eu
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Medical Oncology Unit
Principal Investigator Name
Davide Melisi
Principal Investigator Email
davide.melisi@univr.it
Contact Person Name
Davide Melisi
Contact Person Email
davide.melisi@univr.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Department of Precision Medicine
Principal Investigator Name
Erika Martinelli
Principal Investigator Email
erika.martinelli@unicampania.it
Contact Person Name
Erika Martinelli
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
U.O.C. Immunoterapia Oncologica
Principal Investigator Name
Michele Maio
Principal Investigator Email
maio@unisi.it
Contact Person Name
Michele Maio
Contact Person Email
maio@unisi.it
Site Name
Azienda Ospedaliero Universita' Delle Marche
Department Name
Dipartimento di Medicina Interna – SOD Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriunitimarche.it
Contact Person Name
Rossana Berardi
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2
Principal Investigator Name
Gianluca Masi
Principal Investigator Email
gianluca.masi@unipi.it
Contact Person Name
Gianluca Masi
Contact Person Email
gianluca.masi@unipi.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale Addome
Principal Investigator Name
Antonio Avallone
Principal Investigator Email
a.avallone@istitutotumori.na.it
Contact Person Name
Antonio Avallone
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncology
Principal Investigator Name
Virginia Quarà
Principal Investigator Email
virginia.quara@ircc.it
Contact Person Name
Virginia Quarà
Contact Person Email
virginia.quara@ircc.it

Sponsor

Primary sponsor

Full Name
Transthera Sciences (Nanjing) Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Contract research organisations

Name
Syneos Health Netherlands B.V.
Responsibilities
Sponsor duties codes include: [1,10,11,12,13,2,3,5,6,7,8] (multiple operational responsibilities listed in CTIS record)
Name
PPD International Holdings LLC
Responsibilities
Samples distribution from Site to analysis central labs; sponsorDuties codes [15,2]
Name
Bioclinica Inc.
Responsibilities
Medical Imaging and related duties (sponsorDuties codes [14,15])
Name
Medidata Solutions Inc.
Responsibilities
eClinical platform / data services (sponsorDuties codes [3,7])
Name
Primera Analytical Solutions Corp.
Responsibilities
Laboratory/analysis responsibilities (sponsorDuties code [4])

Third parties

  • {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Epl Pathology Archives LLC","duties_or_roles":"Sample storage (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [3,7]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [14,15] (Medical Imaging)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Samples distribution from Site to analysis central labs (sponsorDuties codes: [15,2])","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Extensive sponsorDuties codes: [1,10,11,12,13,2,3,5,6,7,8] (various CRO functions)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tinengotinib 4 mg
Active Substance
TINENGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Not Authorised
Starting Dose
Part A evaluated doses: 8 mg QD and 10 mg QD (dose selection); available tablet strengths 4 mg
Dose Levels
4 mg (tablet strength listed); study doses include 8 mg and 10 mg once daily (QD)
Frequency
Once daily
Maximum Dose
10 mg
Dose Escalation Increase
Initial 8 mg QD and following 10 mg QD (Part A dose selection)
Investigational Product Name
Tinengotinib 5 mg
Active Substance
TINENGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Not Authorised
Starting Dose
Part A evaluated doses: 8 mg QD and 10 mg QD (dose selection); available tablet strength 5 mg
Dose Levels
5 mg (tablet strength listed); study doses include 8 mg and 10 mg once daily (QD)
Frequency
Once daily
Maximum Dose
10 mg
Dose Escalation Increase
Initial 8 mg QD and following 10 mg QD (Part A dose selection)
Investigational Product Name
Tinengotinib 6 mg
Active Substance
TINENGOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Not Authorised
Starting Dose
Part A evaluated doses: 8 mg QD and 10 mg QD (dose selection); available tablet strength 6 mg
Dose Levels
6 mg (tablet strength listed); study doses include 8 mg and 10 mg once daily (QD)
Frequency
Once daily
Maximum Dose
10 mg
Dose Escalation Increase
Initial 8 mg QD and following 10 mg QD (Part A dose selection)
Investigational Product Name
Oxaliplatin Hikma 5 mg/ml
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
85 mg/m2
Investigational Product Name
Oxaliplatin AqVida 5 mg/ml
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
85 mg/m2
Investigational Product Name
Irinotecan Hikma 20 mg/ml
Active Substance
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
180 mg/m2
Investigational Product Name
Irinotecan HCl AqVida 20 mg/ml
Active Substance
IRINOTECAN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
180 mg/m2
Investigational Product Name
5-Fluorouracil Ebewe 50 mg/ml
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
Intravenous bolus injection / infusion
Authorisation Status
Authorised
Maximum Dose
2800 mg/m2
Investigational Product Name
Benda-5 FU 50 mg/ml
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
Intravenous bolus injection / infusion
Authorisation Status
Authorised
Maximum Dose
2800 mg/m2
Investigational Product Name
BENDAFOLIN 10 mg/ml (Folinic acid)
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
200 mg/m2
Investigational Product Name
Ribofolin® 10 mg/ml (Folinic acid)
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
200 mg/m2
Combination Treatment
Yes

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