Clinical trial • Phase II • Oncology

ZOLBETUXIMAB for Metastatic pancreatic adenocarcinoma

Phase II trial of ZOLBETUXIMAB for Metastatic pancreatic adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic pancreatic adenocarcinoma
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
23-04-2024
First CTIS Authorization Date
14-06-2024

Trial design

Randomised, open-label, nab-paclitaxel + gemcitabine (nab-p + gem); dose/schedule not specified in available documents-controlled, adaptive Phase II trial across 47 sites in Italy, Ireland, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Nab-Paclitaxel + Gemcitabine (Nab-P + GEM); dose/schedule not specified in available documents
Adaptive
True, Safety Lead-in Phase to confirm RP2D based on DLTs; detailed dose escalation rules/interim analyses/stopping rules not specified in available documents
Biomarker Stratified
True, CLDN18.2 expression (≥75% tumor cells with moderate to strong membranous staining by central IHC)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
283

Eligibility

Recruits 283 IRB/IEC approved written informed consent and privacy language must be obtained from the subject or legally authorized representative prior to any study related procedures; subjects must be considered an adult according to local regulation at the time of signing informed consent..

Pregnancy Exclusion
A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies: ● Not a woman of childbearing potential (WOCBP) as defined in the Protocol. OR ● WOCBP who agrees to follow the contraceptive guidance as defined in the Protocol throughout the treatment period and for at least 6 months after the final study drug administration.
Vulnerable Population
IRB/IEC approved written informed consent and privacy language must be obtained from the subject or legally authorized representative prior to any study related procedures; subjects must be considered an adult according to local regulation at the time of signing informed consent.

Inclusion criteria

  • {"criterion_text":"- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for United States sites) must be obtained from the subject or legally authorized representative prior to any study related procedures (including withdrawal of prohibited medication, if applicable)."}
  • {"criterion_text":"- Subject has histologically or cytologically confirmed adenocarcinoma of pancreas."}
  • {"criterion_text":"- Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy. • Prior treatment with 5-FU or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed (if there is lingering toxicity, then the sponsor should be consulted). • If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy. • Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible."}
  • {"criterion_text":"- Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measureable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy."}
  • {"criterion_text":"- Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing. Physical or Laboratory Findings"}
  • {"criterion_text":"- Subject has ECOG performance status of 0 or 1"}
  • {"criterion_text":"- Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator."}
  • {"criterion_text":"- Subject must meet all of the following criteria based on the laboratory tests collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used. •Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment) •Absolute neutrophil count ≥ 1.5 x 109 /L •Platelets ≥ 100 x 109 /L •Albumin ≥ 2.5 g/dL •Total bilirubin ≤ 1.5 x upper limit of normal (ULN) •Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present) •Estimated creatinine clearance ≥ 30 mL/min •Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)"}
  • {"criterion_text":"- Subject is considered an adult according to local regulation at the time of signing informed consent."}
  • {"criterion_text":"- Subject agrees not to participate in another interventional study while receiving study drug in present study."}
  • {"criterion_text":"- A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies: ● Not a woman of childbearing potential (WOCBP) as defined in the Protocol. OR ● WOCBP who agrees to follow the contraceptive guidance as defined in the Protocol throughout the treatment period and for at least 6 months after the final study drug administration."}
  • {"criterion_text":"- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration."}
  • {"criterion_text":"- Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration."}
  • {"criterion_text":"- A male subject with female partner(s) of child-bearing potential must agree to use contraception as detailed in the Protocol during the treatment period and for at least 6 months after the final study drug administration."}
  • {"criterion_text":"- A male subject must not donate sperm during the treatment period and for 6 months after the final study drug administration."}
  • {"criterion_text":"- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration."}

Exclusion criteria

  • {"criterion_text":"- Subject has received other investigational treatment within 28 days prior to randomization."}
  • {"criterion_text":"- Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomizatio"}
  • {"criterion_text":"- Subject has significant cardiovascular disease, including: ● Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization; ● History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); ● QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects; ● Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible.)"}
  • {"criterion_text":"- Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma"}
  • {"criterion_text":"- Subject has known peripheral sensory neuropathy ≥ Grade 2 per CTCAE v.4.03 unless the absence of deep tendon reflexes is the sole neurological abnormality"}
  • {"criterion_text":"- Subject has had a major surgical procedure ≤ 28 days prior to randomization."}
  • {"criterion_text":"- Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization."}
  • {"criterion_text":"- Psychiatric illness or social situations that would preclude study compliance per investigator's judgment."}
  • {"criterion_text":"- Subject has another malignancy for which treatment is required per investigator's clinical judgment"}
  • {"criterion_text":"- Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator."}
  • {"criterion_text":"- Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity."}
  • {"criterion_text":"- Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed."}
  • {"criterion_text":"- Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies."}
  • {"criterion_text":"- Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment."}
  • {"criterion_text":"- Subject has a known history of a positive test for human immunodeficiency virus infection or known active Hepatitis B (positive HBs antigen [Ag]) or Hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements. For subjects who are negative for HBs Ag, but Hepatitis B core antibody positive, a Hepatitis B virus DNA test will be performed and if positive, the subject will be excluded. Subjects with positive serology but negative Hepatitis C virus RNA test results are eligible. Subjects treated for hepatitis C with undetectable viral load results are eligible."}
  • {"criterion_text":"- Subject has a history of interstitial pneumonia or pulmonary fibrosis."}
  • {"criterion_text":"- Subject has pleural effusion or ascites ≥ Grade 3 per CTCAE v 4.03."}
  • {"criterion_text":"- Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ● Confirm RP2D as assessed by DLTs (Safety Lead-in Phase)","definition_or_measurement_approach":"Confirm RP2D as assessed by DLTs during Safety Lead-in Phase (assessed by dose-limiting toxicities)."}
  • {"endpoint_text":"- ● Safety and tolerability as measured by AEs, laboratory test results, vital signs, ECGs and ECOG performance status.","definition_or_measurement_approach":"Safety and tolerability measured by adverse events (AEs), laboratory test results, vital signs, ECGs, and ECOG performance status."}
  • {"endpoint_text":"- ● OS, defined as the time from the date of randomization until the date of death from any cause","definition_or_measurement_approach":"Overall Survival (OS): time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- ● PFS, defined as the time from the date of randomization until the date of radiological PD per RECIST 1.1 by local investigator evaluation, or death from any cause, whichever is earliest","definition_or_measurement_approach":"Progression-Free Survival (PFS): time from randomization to radiological progressive disease per RECIST 1.1 by local investigator evaluation, or death from any cause, whichever occurs first."}
  • {"endpoint_text":"- ● ORR, defined as the proportion of subjects who have a best overall response of CR or PR as assessed by local investigator evaluation per RECIST 1.1","definition_or_measurement_approach":"Objective Response Rate (ORR): proportion of subjects with best overall response of CR or PR per RECIST 1.1 by local investigator evaluation."}
  • {"endpoint_text":"- Pharmacokinetic parameters of zolbetuximab, Nab-P and GEM (AUCinf, AUCinf [%extrap], AUClast, Cmax, Ctrough, tmax, t1/2, tlast, CL, Vz, as appropriate","definition_or_measurement_approach":"Pharmacokinetic parameters for zolbetuximab, Nab‑Paclitaxel and Gemcitabine including AUCinf, AUClast, Cmax, Ctrough, tmax, t1/2, CL, Vz, etc."}
  • {"endpoint_text":"- DCR, defined as the proportion of subjects who have a best overall response of CR, PR or stable disease (SD) as assessed by local investigator evaluation per RECIST 1.1","definition_or_measurement_approach":"Disease Control Rate (DCR): proportion with best overall response of CR, PR or SD per RECIST 1.1 by local investigator evaluation."}
  • {"endpoint_text":"- ● DOR, defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by local investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earlies","definition_or_measurement_approach":"Duration of Response (DOR): time from first documented CR/PR until PD per RECIST 1.1 by local investigator evaluation or death, whichever is earlier."}
  • {"endpoint_text":"- Time to worsening of pancreatic pain and GHS/QoL as measured by QLQ-C30, QLQ-PAN26, and PGIS as key HRQOL endpoints","definition_or_measurement_approach":"Time to worsening of pancreatic pain and global health status/quality of life measured by EORTC QLQ-C30, QLQ-PAN26, and PGIS questionnaires."}
  • {"endpoint_text":"- HRQoL, as collected viameasured by EORTC QLQ-C30, EORTC QLQPAN26 (including remaining domains besides pancreatic pain), EORTC QLQ-C30 (including remaining domains besides GHS/QoL), EQ-5D-5L, PGIS and PGIC questionnaires","definition_or_measurement_approach":"Health-related quality of life collected using EORTC QLQ-C30, QLQ-PAN26, EQ-5D-5L, PGIS and PGIC questionnaires."}
  • {"endpoint_text":"- Serum CA19-9 change from baseline","definition_or_measurement_approach":"Change in serum CA19-9 from baseline."}
  • {"endpoint_text":"- Immunogenicity of zolbetuximab as measured by the frequency of anti-drug antibody (ADA) positive subjects.","definition_or_measurement_approach":"Immunogenicity assessed by frequency of subjects positive for anti-drug antibodies (ADA) to zolbetuximab."}

Recruitment

Planned Sample Size
283
Recruitment Window Months
81
Consent Approach
IRB/IEC approved written informed consent and privacy language must be obtained from the subject or legally authorized representative prior to any study related procedures. Subjects must be considered an adult according to local regulation at time of signing informed consent. Subject information and informed consent form documents available in multiple language versions (patient-facing documents and ICFs available in English, French, Italian, Spanish as provided).

Geography

Total Number Of Sites
47
Total Number Of Participants
113

Italy

Latest Decision Or Authorization Date
27-03-2025
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Oncology and Ematology
Contact Person Name
Armando Santoro
Contact Person Email
armando.santoro@humanitas.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
UO Oncology
Contact Person Name
Renato Ferraris
Contact Person Email
renato.ferraris@ircc.it
Site Name
Fondazione Poliambulanza
Department Name
Onology Operational Unit
Contact Person Name
Alberto Zaniboni
Site Name
Careggi University Hospital
Department Name
UO Oncology
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
UO Oncology
Contact Person Name
Maria Bonomi
Contact Person Email
maria-bonomi@asst-cremona.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
UO Oncology
Contact Person Name
Nicola Fazio
Contact Person Email
Nicola.fazio@ieo.it
Site Name
Fondazione Poliambulanza
Department Name
Onology Operational Unit

Ireland

Latest Decision Or Authorization Date
31-03-2025
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
St Vincent's University Hospital
Department Name
Oncology
Contact Person Name
Sean Raymond McDermot
Contact Person Email
ray.mcdermott@tuh.ie

Spain

Latest Decision Or Authorization Date
28-03-2025
Number Of Sites
18
Number Of Participants
27

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Rocío Garcia Carbonero
Contact Person Email
rgcarbonero@gmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Oncology
Contact Person Name
Alberto Rodrigo Cáceres
Contact Person Email
arodrigo.lleida.ics@gencat.cat
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncology
Contact Person Name
Roberto Antonio Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Contact Person Name
Eduardo Ceballos Barbancho
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Adelaida Garcia Velasco
Contact Person Email
agvelasco@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Tamara Saurí Nadal
Contact Person Email
sauri@clinic.cat
Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
Oncology
Contact Person Name
Nuria Ruiz Miravet
Contact Person Email
nruiz@uji.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Sonia Candamio Folgar
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Juan José Garcia Mosquera
Contact Person Email
jjgarcia@oncorosell.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Inmaculada Ales Diaz
Contact Person Email
inales@hotmail.com
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncology
Contact Person Name
Cristina Bugés Sánchez
Contact Person Email
cbuges@iconcologia.net
Site Name
MD Anderson Cancer Center (Madrid)
Department Name
Oncology
Contact Person Name
Sara Encinas García
Contact Person Email
sencinas@mdanderson.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Victoria López Gómez
Contact Person Email
vlopezg@salud.madrid.org
Site Name
Institut Catala D'oncologia (L'Hospitalet de Llobregat)
Department Name
Oncology
Contact Person Name
Berta Laquente Saez
Contact Person Email
blaquente@iconcologia.net
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Laura Visa Turmo
Contact Person Email
lvisa@psmar.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Contact Person Name
Paula Ribera
Contact Person Email
pribera@tauli.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Teresa Macarulla Mercade
Contact Person Email
tmacarulla@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Mariano Ponz Sarvisé
Contact Person Email
mponz@unav.es

France

Latest Decision Or Authorization Date
25-08-2025
Number Of Sites
21
Number Of Participants
60

Sites

Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service de Gastroenterologie
Contact Person Name
Franck Audemar
Contact Person Email
faudemar@ch-cotebasque.fr
Site Name
Besancon University Hospital Center
Department Name
Service d’Oncologie Médicale
Contact Person Name
Christophe Borg
Contact Person Email
christophe.borg@efs.sante.fr
Site Name
Hopital Nord Franche Comte
Department Name
Service d’Oncologie
Contact Person Name
Christophe Borg
Contact Person Email
christophe.borg@efs.sante.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service de Hépato-Gastroenterologie
Contact Person Name
David Sefrioui
Contact Person Email
David.sefrioui@chu-rouen.fr
Site Name
Institut Bergonie
Department Name
Service d’Oncologie Médicale
Contact Person Name
Simon Pernot
Contact Person Email
s.pernot@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service Unité d’Onco-Gastroentérologie HC
Contact Person Name
Thierry Lecomte
Site Name
Groupe Hospitalier Saint Vincent
Department Name
Service d’Oncologie
Contact Person Name
Louis-Marie Dourthe
Contact Person Email
lmdourthe@solcrr.org
Site Name
Medipole De Nancy
Department Name
Service d’Oncologie
Contact Person Name
Raafet AFFI
Contact Person Email
r.affi@ilcgroupe.fr
Site Name
Hospital Edouard Herriot
Department Name
Service d’Oncologie médicale
Contact Person Name
Julien Forestier
Contact Person Email
Julien.forestier@chu-lyon.fr
Site Name
Centre Antoine Lacassagne
Department Name
Service d’Oncologie médicale
Contact Person Name
Ludovic Evesque
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Service de Hépato-Gastro-Enterologie
Contact Person Name
Lucile Bauguion
Contact Person Email
Lucile.bauguion@ght85.fr
Site Name
Centre Francois Baclesse
Department Name
Unité IRIS (Investigation, Recherche, Innovation et Soins)
Contact Person Name
Mélanie Dos Santos
Site Name
Polyclinique De Blois
Department Name
Service d’Oncologie
Contact Person Name
Philippe Laplaige
Contact Person Email
Dr.laplaige@wanadoo.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de Cancérologie et d’Imagerie
Contact Person Name
Jean-Philippe Metges
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Service d’Oncologie Médicale
Contact Person Name
Jerôme Martin-Babau
Contact Person Email
j.martin@cario-sante.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Hépato-Gastro-Entérologie et Assistance Nutritionnelle
Contact Person Name
Marion Chauvenet
Contact Person Email
marion.chauvenet@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d’Hepato-gastroenterologie et Oncologie Digestive
Contact Person Name
Jean-Frederic Blanc
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Service d’Hepato-gastro-enterologie et endoscopies
Contact Person Name
Mathieu Baconnier
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d’Oncologie Médicale
Contact Person Name
Sandrine Hiret
Site Name
Institut Gustave Roussy
Department Name
Service d’Oncologie Digestive
Contact Person Name
Michel Ducreux
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d’Hepato-gastroenterologie et Oncologie Digestive
Contact Person Name
Gael Roth
Contact Person Email
groth@chu-grenoble.fr

Sponsor

Primary sponsor

Full Name
Astellas Pharma Global Development Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: ["1","12","13","6","8"]
Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes include ["4"] and site contracts and payments (code "15")
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: ["3"]

Third parties

  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Japan","full_name":"Shin Nippon Biomedical Laboratories Ltd.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Packaging and Distribution (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\",\"13\",\"6\",\"8\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"distribution (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Almac Pharmaceutical Services Pte Ltd","duties_or_roles":"Packaging distribution and returns (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Packaging, Distribution and Returns (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC (additional entries)","duties_or_roles":"return (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc. (alternate address)","duties_or_roles":"site contracts and payments (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"biorepository (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC (additional entry)","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC (returns)","duties_or_roles":"returns (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA questionnaires (sponsorDuties code: \"15\")","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC (additional)","duties_or_roles":"return (sponsorDuties code: \"15\")","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ASP8951
Active Substance
ZOLBETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus: 1
Orphan Designation
Yes
Maximum Dose
1000 mg/m2 (maxTotalDoseAmount provided in record)
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
prodAuthStatus: 2
Maximum Dose
125 mg/m2 (maxDailyDoseAmount provided in record)
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
prodAuthStatus: 2
Maximum Dose
1000 mg/m2 (maxDailyDoseAmount provided in record)
Combination Treatment
Yes

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