Clinical trial • Phase I/II • Oncology

PATRITUMAB DERUXTECAN for Colorectal carcinoma | Biliary tract carcinoma | Hepatocellular carcinoma

Phase I/II trial of PATRITUMAB DERUXTECAN for Colorectal carcinoma | Biliary tract carcinoma | Hepatocellular carcinoma. open-label, adaptive.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Colorectal carcinoma | Biliary tract carcinoma | Hepatocellular carcinoma
Trial Stage
Phase I/II
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
02-08-2024
First CTIS Authorization Date
06-11-2024

Trial design

open-label, adaptive Phase I/II trial across 10 sites in France, Italy, Spain.

Open Label
Yes
Adaptive
True, includes dose-escalation/dose-finding design with cohorts and determination of a preliminary RP2D (Cohort 3) and expansion cohorts (Cohorts 1, 2, 4).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
222

Eligibility

Recruits 222 No vulnerable population selected (isVulnerablePopulationSelected=false); trial enrols adults only; consent to be obtained from participants (see country-specific informed consent documents listed)..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false); trial enrols adults only; consent to be obtained from participants (see country-specific informed consent documents listed).

Inclusion criteria

  • {"criterion_text":"- Has one of the following cancers: • Unresectable or metastatic colorectal cancer • Advanced and/or unresectable biliary tract cancer (BTC) • Hepatocellular carcinoma (HCC) not amenable to locoregional therapy • Locally advanced unresectable or metastatic gastroesophageal cancer"}
  • {"criterion_text":"- Has received prior therapy for the cancer"}
  • {"criterion_text":"- Has recovered from any side effects due to previous cancer treatment"}

Exclusion criteria

  • {"criterion_text":"- Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening"}
  • {"criterion_text":"- Has clinically severe respiratory compromise (based on the investigator’s assessment) resulting from intercurrent pulmonary illnesses"}
  • {"criterion_text":"- Has evidence of any leptomeningeal disease"}
  • {"criterion_text":"- Has clinically significant corneal disease"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"}
  • {"criterion_text":"- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)","definition_or_measurement_approach":"Count of participants experiencing DLT during the dose-escalation phase (DLT definition not provided in the record)."}
  • {"endpoint_text":"- Number of Participants with One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants with ≥1 adverse event (AE)."}
  • {"endpoint_text":"- Number of Participants who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue the study intervention because of an adverse event."}
  • {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"Confirmed ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) (stated in the trial objectives)."}

Secondary endpoints

  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR as assessed by BICR per RECIST 1.1 (specified in secondary objectives)."}
  • {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":"PFS as assessed by BICR per RECIST 1.1."}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (time from defined baseline to death from any cause)."}
  • {"endpoint_text":"- Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan","definition_or_measurement_approach":"Pharmacokinetic measurement: maximum plasma concentration (Cmax) of patritumab deruxtecan."}
  • {"endpoint_text":"- Trough Concentration (Ctrough) of Patritumab Deruxtecan","definition_or_measurement_approach":"Pharmacokinetic measurement: trough (Ctrough) concentration of patritumab deruxtecan."}

Recruitment

Planned Sample Size
222
Recruitment Window Months
47
Consent Approach
Informed consent is required from participants. Subject information and informed consent forms are provided (country-specific ICF documents listed for France, Italy and Spain in the trial documents). No assent provisions are indicated (trial enrols adults).

Geography

Total Number Of Sites
10
Total Number Of Participants
48

France

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
537
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Hopital De La Croix-Rousse
Department Name
Service d'hépatologie et gastroentérologie
Contact Person Name
Philippe Merle
Contact Person Email
philippe.merle@inserm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Liver Cancer and Therapeutic Innovation Unit
Contact Person Name
Mohamed Bouattour
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Digestive oncology
Contact Person Name
Julien Edeline
Contact Person Email
j.edeline@rennes.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
03-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
561
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Contact Person Name
Giampaolo Tortora
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Falck, Dipartimento di Ematologia e Oncologia
Contact Person Name
Salvatore Siena
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica I
Contact Person Name
Filippo Pietrantonio

Spain

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
555
Number Of Sites
4
Number Of Participants
21

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Medical Oncology Department
Contact Person Name
Paula Jiménez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Contact Person Name
Jorge Hernando Cubero
Contact Person Email
jhernando@vhio.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncology Department
Contact Person Name
Javier Sastre Valera
Contact Person Email
jsastrev@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología
Contact Person Name
Andrés Muñoz Martín

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
code:4
Name
Icon Clinical Research Limited
Responsibilities
code:4
Name
Icon Clinical Research Limited
Responsibilities
Central imaging
Name
Bioclinica Inc.
Responsibilities
Interstitial Lung Disease (ILD) Adjudication
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Almac Clinical Technologies LLC
Responsibilities
code:3

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Interstitial Lung Disease (ILD) Adjudication","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-1022
Active Substance
PATRITUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION

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