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New combo therapy shows promise for hard-to-treat stomach and bowel cancers

NCT ID NCT05104567

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called SAR444245 combined with other cancer treatments in 138 adults with advanced gastrointestinal cancers, including esophageal, stomach, liver, and colorectal cancer. The goal was to see if the combination could shrink tumors. The study is complete, and results will help determine if this approach is effective for patients who have not responded to standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

138 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus colorectal cancer colorectal neoplasm esophageal adenocarcinoma esophageal squamous cell carcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Gastric cancer Hepatocellular carcinoma Oesophageal adenocarcinoma Oesophageal squamous cell carcinoma

Contacts and locations

Locations

  • AdventHealth Orlando Site Number : 8400005

    Orlando, Florida, 32804, United States

  • City of Hope Site Number : 8400007

    Duarte, California, 91010, United States

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Brussels, BE-1200, Belgium

  • Investigational Site Number : 0560003

    Edegem, 2650, Belgium

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1560002

    Wuhan, 430022, China

  • Investigational Site Number : 2500001

    Villejuif, 94800, France

  • Investigational Site Number : 2500002

    Paris, 75015, France

  • Investigational Site Number : 2500004

    Bordeaux, 33075, France

  • Investigational Site Number : 2500005

    Poitiers, 86021, France

  • Investigational Site Number : 2500006

    Brest, 29200, France

  • Investigational Site Number : 3800001

    Rozzano, Lombardy, 20089, Italy

  • Investigational Site Number : 3800002

    Milan, 20133, Italy

  • Investigational Site Number : 3800003

    Milan, 20132, Italy

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 5280003

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240002

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240003

    Madrid / Madrid, Madrid, Comunidad de, 28007, Spain

  • Investigational Site Number : 7240004

    Madrid / Madrid, Madrid, Comunidad de, 28050, Spain

  • Investigational Site Number : 7240005

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 7240101

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Seattle Cancer Care Alliance Site Number : 8400009

    Seattle, Washington, 98115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.