A study of SAR444245 combined with other anticancer therapies for the treatment of participants with gastrointestinal cancer (Master protocol)

Phase 1

• Conditions: Advanced and metastatic gastrointestinal cancer; MedDRA version: 21.0Level: PTClassification code 10061534Term: Oesophageal squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002181-41-NL
• Lead Sponsor: Sanofi-Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Participant must be =18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
Participants with:
- Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype
- Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.

Participants (all sub-studies) must have at least one measurable lesion
Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01 and sub-study02 .

Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
- to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment
- and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.

Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.

Capable of giving signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of =2
- Poor organ function
- Active brain metastases or leptomeningeal disease.
- History of allogenic or solid organ transplant.
- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration
- Comorbidity requiring corticosteroid therapy
- Antibiotic use (excluding topical antibiotics) =14 days prior to first dose of IMP
- Severe or unstable cardiac condition within 6 months prior to starting study treatment
- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
- Participants with baseline SpO2 =92% (without oxygen therapy).
- Participant has received prior IL2-based anticancer treatment.
- Participants on sub-study02 cohort B1 and B2 or sub-study 04 – cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified