A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

Completed · Phase 2

Conditions studied: Oesophageal Squamous Cell Carcinoma, Gastric Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Oesophageal Adenocarcinoma

In brief

The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens. Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens. Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

Key facts

Study ID: NCT05104567
Run by: Sanofi
People needed: 138
Starts: 2021-12-09
Expected to finish: 2024-09-09
Last updated by the study team: 2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by AASLD criteria in cirrhotic patients.
Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible.
Participants (all sub-studies) must have at least one measurable lesion.
Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator's discretion for the other cohorts.
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 120 days (for Cohort A, B1, B2, B3, C, and D1) or 60 days (for Cohort D2) [corresponding to the time needed to eliminate any study intervention(s)].
and to refrain from donating or cryopreserving eggs for 120 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 3 days [corresponding to time needed to eliminate SAR444245] after the last dose of SAR444245.
Capable of giving signed informed consent.

You may not qualify if…

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 (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded).
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 or live attenuated-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

City of Hope Site Number : 8400007 — Duarte, California, United States
AdventHealth Orlando Site Number : 8400005 — Orlando, Florida, United States
Seattle Cancer Care Alliance Site Number : 8400009 — Seattle, Washington, United States
Investigational Site Number : 0560002 — Brussels, Belgium
Investigational Site Number : 0560003 — Edegem, Belgium
Investigational Site Number : 0560001 — Leuven, Belgium
Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560002 — Wuhan, China
Investigational Site Number : 2500004 — Bordeaux, France
Investigational Site Number : 2500006 — Brest, France
Investigational Site Number : 2500002 — Paris, France
Investigational Site Number : 2500005 — Poitiers, France
Investigational Site Number : 2500001 — Villejuif, France
Investigational Site Number : 3800001 — Rozzano, Lombardy, Italy
Investigational Site Number : 3800003 — Milan, Italy
Investigational Site Number : 3800002 — Milan, Italy
Investigational Site Number : 5280001 — Amsterdam, Netherlands
Investigational Site Number : 5280003 — Rotterdam, Netherlands
Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004 — Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003 — Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240002 — Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006 — Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005 — Santander, Cantabria, Spain

Full record on ClinicalTrials.gov

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