Clinical trial • Phase I/II • Oncology

EPCORITAMAB for Chronic lymphocytic leukemia|Richter's syndrome

Phase I/II trial of EPCORITAMAB for Chronic lymphocytic leukemia|Richter's syndrome. open-label, none/not specified-controlled, adaptive. 78 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Chronic lymphocytic leukemia|Richter's syndrome
Trial Stage
Phase I/II
Drug Modality
Bispecific antibody|Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
04-04-2024
First CTIS Authorization Date
14-05-2024

Trial design

open-label, none/not specified-controlled, adaptive Phase I/II trial in Spain, Italy, Germany and others.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True, dose-escalation design to identify RP2D and MTD, expansion cohorts and safety run-in cohorts (combination therapy dose escalation and expansion).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
78

Eligibility

Recruits 78 Population flagged as vulnerable in CTIS. Consent handling: "All Subjects • Subject must sign an ICF, prior to any Screening procedures • Must be at least 18 years of age" — informed consent is required from each adult participant; no paediatric consent/assent procedures (minimum age 18)..

Pregnancy Exclusion
Subject is a woman who is pregnant or breastfeeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab.
Vulnerable Population
Population flagged as vulnerable in CTIS. Consent handling: "All Subjects • Subject must sign an ICF, prior to any Screening procedures • Must be at least 18 years of age" — informed consent is required from each adult participant; no paediatric consent/assent procedures (minimum age 18).

Inclusion criteria

  • {"criterion_text":"- All Subjects • Subject must sign an ICF, prior to any Screening procedures • Must be at least 18 years of age • ECOG performance status score of 0,1 or 2 • Evidence of CD20 positivity in a sample representative of the disease (eg, tumor biopsy/peripheral blood/bone arrow) at Screening • Has acceptable laboratory parameters • A woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab. • A woman of childbearing potential must have a negative serum (betahCG) pregnancy test at Screening and a negative serum or urine pregnancy test before treatment administration on Day 1 of every cycle. • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after last treatment. • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control."}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects With R/R CLL– Dose Escalation Monotherapy (All Cohorts) and Expansion Monotherapy (Arm 1) • Must have active CLL/SLL disease that needs treatment per iwCLL • R/R CLL after receiving at least 2 prior lines of therapy. • Diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek et al., 2018a) • Must take prophylaxis for TLS"}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects With Richter's Syndrome – Expansion Monotherapy Arm 2A • Must have measurable disease as determined by FDG- PET CT and a CT scan (or MRI) • Must provide a mandatory FFPE tumor tissue sample;"}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects With Richter's Syndrome – Lenalidomide Combination Therapy Expansion Arm 2B • Have tumor biopsy-proven CD20+ DLBCL and a clinical history of CLL/SLL. • Deemed as ineligible for chemoimmunotherapy • Eligible for treatment with lenalidomide. • Must have measurable disease as determined by FDG- PET CT and a CT scan (or MRI) • Must provide a mandatory FFPE tumor tissue sample; • Females of childbearing potential must use 2 forms of contraception • A woman of childbearing potential must have a negative serum (betahCG) pregnancy test • Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide"}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects With Richter's Syndrome – R-CHOP Combination Therapy Expansion Arm 2C • Have tumor biopsy-proven CD20+ DLBCL and have a clinical history of CLL/SLL. • Eligible to receive R-CHOP per investigator determination. • Must have measurable disease as determined by FDG- PET CT and a CT scan (or MRI) • Must provide a mandatory FFPE tumor tissue sample;"}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects with R/R CLL – Venetoclax Combination Therapy Dose Escalation Cohorts and Expansion Arm 3 • Must have active CLL/SLL disease that needs treatment per iwCLL"}
  • {"criterion_text":"- Inclusion Criteria Specific to Subjects with R/R CLL – Pirtobrutinib Combination Therapy Safety Run-in CP cohorts and Expansion Arm 4: • Must have active CLL/SLL disease that needs treatment with at least 1 of the criteria being met. • Presence of measurable disease. • Previous treatment with at least one and a maximum 3 prior lines of therapy and must include a covalent BTKi. • Diagnosis of CLL/SLL that meets published iwCLL criteria at the time of diagnosis. • Females of childbearing potential must use highly effective contraceptive measures while taking pirtobrutinib and for 28 days after the last dose. • A woman must agree not to breastfeed a child during treatment and until one week after last dose. • A man who is sexually active with a woman of childbearing potential must use an effective method of contraception during treatment and for 3 months after last dose"}

Exclusion criteria

  • {"criterion_text":"- Subject received prior treatment with a CD3×CD20 bsAb."}
  • {"criterion_text":"- Subject has history or presence of clinically relevant disorder affecting the CNS"}
  • {"criterion_text":"- ICE score of less than 8 at study entry"}
  • {"criterion_text":"- Subject has known past or current malignancy other than inclusion diagnosis, except for: a. Cervical carcinoma of Stage 1B or less b. Non-invasive basal cell or squamous cell skin carcinoma c. Non-invasive, superficial bladder cancer d. Prostate cancer with a current PSA level <0.1 ng/mL e. Any curable cancer with a CR of >2 years duration"}
  • {"criterion_text":"- Subject has suspected allergies, hypersensitivity, or intolerance to epcoritamab or another anti-CD20 mAb or its excipients (refer to the IB for more information)."}
  • {"criterion_text":"- Active HBV (DNA PCR-positive). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy."}
  • {"criterion_text":"- Any of the following active infections: -\tHepatitis C (RNA PCR-positive infection). Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable. Known Human T cell leukemia virus infection -Active CMV infection"}
  • {"criterion_text":"- Subject is a woman who is pregnant or breastfeeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab."}
  • {"criterion_text":"- Subject is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab"}
  • {"criterion_text":"- Subject received any prior allogeneic HSCT or solid organ transplantation"}
  • {"criterion_text":"- Subject received treatment with an anticancer agent, as follows: - Subject received treatment with an investigational drug, within 4 weeks or 5 half lives, whichever is shorter, prior to the first dose of epcoritamab."}
  • {"criterion_text":"- Subject has autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy"}
  • {"criterion_text":"- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia (requiring >20 mg of prednisolone daily) or other concurrent uncontrolled medical conditions."}
  • {"criterion_text":"- Unstable or uncontrolled disease/condition related to or affecting cardiac function, eg, unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association, uncontrolled clinically significant cardiac arrhythmia (CTCAE v5.0 grade 2 or higher), or clinically significant ECG abnormalities"}
  • {"criterion_text":"- Myocardial infarction, intracranial bleed, or stroke within the past 6 months"}
  • {"criterion_text":"- Subject age ≥75 and 2 or more active grade ≥2 cardiovascular conditions."}
  • {"criterion_text":"- Subject has toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or less except for alopecia and peripheral neuropathy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Monotherapy Cohorts (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS and TLS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Monotherapy (R/R CLL [Arm 1 and 1A] and RS [Arm 2A]): • ORR","definition_or_measurement_approach":"ORR as assessed by the IRC"}
  • {"endpoint_text":"- Dose Escalation Venetoclax Combination Therapy (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Expansion Venetoclax Combination Therapy in R/R CLL (Arm 3) • ORR as assessed by the IRC","definition_or_measurement_approach":"ORR as assessed by the IRC"}
  • {"endpoint_text":"- Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C) • ORR as assessed by the IRC","definition_or_measurement_approach":"ORR as assessed by the IRC"}

Secondary endpoints

  • {"endpoint_text":"- Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]), Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C): • DOR • CR rate (both cohorts)/CRi rate (CLL cohort only) • PR/nPR rate • TTR • PFS • OS • TTNT • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS, and CTLS • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Dose Escalation Venetoclax Combination Therapy (R/R CLL) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Safety Run-in Pirtobrutinib Combination Therapy (R/R CLL – Cohort CP1) • ORR • DOR • CR/CRi rate • TTR •\t PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Incidence of MRD negativity 3 months after Day 1 of last cycle • Duration of MRD negativity • Incidence of ADAs to epcoritamab","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Expansion Pirtobrutinib Combination Therapy in R/R CLL (Arm 4) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • Incidence and severity of AEs and SAEs • Incidence and severity of CRS, ICANS, and CTLS • PK parameters • Incidence of overall MRD negativity • Incidence of MRD negativity 3 months after Day 1 of last cycle • Duration of MRD negativity • Incidence of ADAs to epcoritamab","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
78
Recruitment Window Months
86
Consent Approach
Informed consent: "Subject must sign an ICF, prior to any Screening procedures". Consent provided by adult subjects (minimum age 18). Pregnancy-related partner ICF forms provided. Country/language-specific ICFs available (document list includes language variants: ESP, ITA, FRA, DEU, NLD, POL, ENG, DNK as evidenced by ICF document versions).

Geography

Total Number Of Sites
53
Total Number Of Participants
125

Spain

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
712
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Pablo Javier Mozas Fernández
Contact Person Email
mozas@clinic.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Hematology
Contact Person Name
Sergio Ortegón Alcaide
Contact Person Email
sortegonalcaide@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Contact Person Name
Miguel Argüello de Tomás
Contact Person Email
marguello@santpau.cat
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Hematology
Contact Person Name
Eva González Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Clinical Hematology
Contact Person Name
Laura Abril Sabater
Contact Person Email
labril@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Sergio Ramos Cillan
Contact Person Email
sergioramosc@quironsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Javier López Jiménez
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology and Medical Oncology
Contact Person Name
María José Terol Castera
Contact Person Email
maria.jose.terol@uv.es

Italy

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
711
Number Of Sites
10
Number Of Participants
11

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology
Contact Person Name
Maurizio Martelli
Contact Person Email
martelli@bce.uniroma1.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Hematology
Contact Person Name
Luca Laurenti
Contact Person Email
luca.laurenti@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Onco-Hematology
Contact Person Name
Gianluca Gaidano
Contact Person Email
gianluca.gaidano@med.uniupo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Hematology
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Hematology
Contact Person Name
Umberto Vitolo
Contact Person Email
umberto.vitolo@ircc.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Hematology
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Hematology
Contact Person Name
Alessandra Tucci
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Hematology
Contact Person Name
Candida Vitale
Contact Person Email
candida.vitale@unito.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
Hematology
Contact Person Name
Antonio Cuneo
Contact Person Email
cut@unife.it

Germany

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
712
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin III
Contact Person Name
Stephan Stilgenbauer
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik II
Contact Person Name
Matthias Ritgen
Contact Person Email
m.ritgen@med2.uni-klinik.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Contact Person Name
Barbara Eichhorst
Contact Person Email
barbara.eichhorst@uk-koeln.de

France

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
712
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie Oncologie
Contact Person Name
Catherine Thieblemont
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
CHRU De Nancy
Department Name
Hématologie
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hématologie
Contact Person Name
Romain Guize
Contact Person Email
rguieze@chu-clermontferrand.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Hématologie
Contact Person Name
Katell Le Du
Contact Person Email
dr.ledu@groupeconfluent.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 13)
Department Name
Hématologie
Contact Person Name
Damien Roos-Weil
Contact Person Email
damien.roosweil@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hématologie
Contact Person Name
Emmanuelle Tchernonog
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie/oncologie
Contact Person Name
François-Xavier Gros
Site Name
University Hospital Of Clermont-Ferrand (duplicate listing removed if present)
Site Name
Assistance Publique Hopitaux De Paris (Porte 23)

Czechia

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
711
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interni hematologicka klinika
Contact Person Name
Martin Šimkovič
Contact Person Email
simkovicm@lfhk.cuni.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Michael Doubek
Contact Person Email
doubek.michael@fnbrno.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Contact Person Name
Jana Mihályová
Contact Person Email
jana.feckova.mihalyova@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. interní klinika
Contact Person Name
Marek Trněný
Contact Person Email
trneny@cesnet.cz
Site Name
University Hospital Olomouc
Department Name
Hemato-onkologicka klinika
Contact Person Name
Zuzana Kubova
Contact Person Email
Zuzana.Kubova@fnol.cz

Poland

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
712
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Aidport Sp. z o.o.
Department Name
AIDPORT Sp. z o.o.
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl

Belgium

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
711
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Contact Person Name
Sylvia Snauwaert
Contact Person Email
sylvia.snauwaert@azsintjan.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hematology
Contact Person Name
Fritz Offner
Contact Person Email
fritz.offner@uzgent.be
Site Name
UZ Leuven
Department Name
Hematology
Contact Person Name
Ann Janssens
Contact Person Email
ann.janssens@uzleuven.be

Netherlands

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
708
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
University Hospital Maastricht
Department Name
Hematology
Contact Person Name
Michel van Gelder
Contact Person Email
m.van.gelder@mumc.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Hematology
Contact Person Name
Mark-David Levin
Contact Person Email
m-d.levin@asz.nl
Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Contact Person Name
Anon Karter
Contact Person Email
a.p.kater@amsterdamumc.nl
Site Name
Universiteit Utrecht
Department Name
Hematology
Contact Person Name
Rogier Mous
Contact Person Email
r.mous@umcutrecht.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Contact Person Name
Mar Bellido
Contact Person Email
m.bellido@umcg.nl
Site Name
University Hospital Maastricht (duplicate listing removed if present)

Denmark

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
708
Number Of Sites
6
Number Of Participants
32

Sites

Site Name
Aarhus Universitet
Department Name
Hematology
Contact Person Name
Hans Herluf Bentzen
Contact Person Email
hansbent@rm.dk
Site Name
Sygehus Lillebaelt Vejle Sygehus
Department Name
Hematology
Contact Person Name
Michael Clausen
Contact Person Email
michael.roost.clausen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Hematology
Contact Person Name
Thor Hoyer
Contact Person Email
thhc@rn.dk
Site Name
Rigshospitalet
Department Name
Hematology
Contact Person Name
Martin Hutchings
Contact Person Email
martin.hutchings@regionh.dk
Site Name
Odense University Hospital
Department Name
Hematology
Contact Person Name
Jacob Haaber Christensen
Contact Person Email
jacob.h.christensen@rsyd.dk
Site Name
Zealand University Hospital
Department Name
Hematology
Contact Person Name
Christian Bjorn Poulsen
Contact Person Email
cbpo@regionsjaelland.dk

Sponsor

Primary sponsor

Full Name
Genmab A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Klifo A/S
Name
IQVIA Limited
Responsibilities
Project management, expedited and aggregate safety reporting to investigators and ECs
Name
Fortrea Development Limited
Name
Icon Clinical Research Limited
Responsibilities
Data Entry
Name
Clinipace Inc.
Name
Almac Clinical Services Limited
Responsibilities
Packaging, labelling and distribution of investigational medicinal products
Name
Q Squared Solutions Limited
Name
Endpoint Clinical Inc.

Third parties

  • {"country":"Denmark","full_name":"Klifo A/S","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Image Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Project management, expedited and aggregate safety reporting to investigators and ECs","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROs and ECG analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Laboratory TCR clonality and MDR","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Roche Sequencing Solutions Inc.","duties_or_roles":"ctDNA testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD and TCR sequencing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Packaging, labelling and distribution of investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"ICON Bioanalytical Laboratories","duties_or_roles":"PK & ADA Samples","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Genmab US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Immunohistochemistry","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Epcoritamab
Active Substance
EPCORITAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
1
Orphan Designation
Yes
Investigational Product Name
VENETOCLAX
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Investigational Product Name
Jaypirca 100 mg film-coated tablets
Active Substance
PIRTOBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Orphan Designation
Yes
Investigational Product Name
Jaypirca 50 mg film-coated tablets
Active Substance
PIRTOBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
2
Investigational Product Name
VINCRISTINE
Active Substance
VINORELBINE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
2
Investigational Product Name
PREDNISOLONE
Active Substance
BETAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Investigational Product Name
LENALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Investigational Product Name
RITUXIMAB
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
2
Combination Treatment
Yes

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