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Gastric CancerPhase 2NCT07692204

A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer

A Phase 2 study testing SAR445877 in people with Gastric Cancer and Oesophageal Carcinoma, run by Sanofi at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Oesophageal Carcinoma
What is being tested?
SAR445877
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jul 2026to 2 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age
  • Participant must be at least 18 years of age inclusive (or country's legal age of majority if >18 years), at the time of signing the informed consent.
  • Cancer diagnosis:
  • Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ.
  • Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.
  • Prior anticancer therapy:
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  • Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment or anti-Claudin 18.2 based treatment depending on local standard of care.
  • Measurable Disease:
  • At least 1 measurable lesion per RECIST 1.1 criteria.

Who cannot join

  • Medical conditions
  • Eastern Cooperative Oncology Group(ECOG)performance status of ≥2.
  • Predicted life expectancy ≤3 months.
  • Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment.
  • Active brain metastases or leptomeningeal metastases.
  • Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumor.
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  • History of treatment-related immune-mediated (or immune-related) AEs from immune- modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity, or have not resolved to Grade ≤1.
  • Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine.
  • Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration.
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related AEs (irAEs).
  • Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
  • Organ transplant requiring immunosuppressive treatment.
  • Uncontrolled or active infection with human immunodeficiency virus (HIV ), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency.
  • Note: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

Contact-US@sanofi.com

China1 site, 1 recruiting

  • Investigational Site Number : 1560001

    Shanghai, 200131

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Open-label, Dose Optimization/Expansion Study of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Gastric or Gastroesophageal Junction Cancer

This is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Participants with advanced GC/GEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study.

In this study, SAR445877 will be assessed as a monotherapy in approximately 30 participants with advanced unresectable or metastatic GC or Siewert Type 2 and 3 GEJ, and for whom receiving the standard of care (SOC) is not in his or her best interest, or where no SOC is established. Human epidermal growth factor receptor 2 (HER2) positive cases will not be eligible unless they have progressed on a HER2 targeted therapy. Those participants should have received at least 1 prior line of anti-cancer treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care. Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases are not eligible.

Being tested
SAR445877
Medical subject headings
Stomach Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR445877Drug

    Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

Study groups in NCT07692204
Study groupRoleWhat they receive
SAR445877 dose 1ExperimentalParticipants will receive SAR445877 through IV infusion
Receives: Drug: SAR445877
SAR445877 dose 2ExperimentalParticipants will receive SAR445877 through IV infusion
Receives: Drug: SAR445877

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Objective response rate, which is defined as the proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: From baseline to the end of study, up to approximately 2 years

Secondary outcomes (11)

  1. maximum serum concentration (Cmax)

    Measured: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)

  2. time to maximum concentration (tmax)

    Measured: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)

  3. area under the concentration-time curve over dosing interval (AUCtau)

    Measured: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)

  4. End of infusion serum concentration (Cend of infusion)

    Measured: at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days)

  5. Percentage of participants with presence of anti-drug antibodies (ADA) against SAR445877

    Measured: From the first dose of Cycle 1 to 30 days after last dose of study interventions

  6. Time to response (TTR)

    Time to response (TTR), defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed partial response (PR) or complete response (CR) determined by Investigator per RECIST v1.1

    Measured: From baseline to the end of study, up to approximately 2 years

  7. Duration of response (DOR)

    Duration of response (DOR), defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first

    Measured: From baseline to the end of study, up to approximately 2 years

  8. Clinical benefit rate

    Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST v1.1

    Measured: From baseline to the end of study, up to approximately 2 years

  9. Progression-free survival (PFS)

    Progression-free survival (PFS), defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST v1.1 or death from any cause, whichever occurs first

    Measured: From baseline to the end of study, up to approximately 2 years

  10. Overall survival (OS)

    Overall survival (OS), defined as the time from the first dose of IMP to the date of death due to any cause

    Measured: From baseline to the end of study, up to approximately 2 years

  11. Number of participants with presence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)

    Measured: The time from the first dose of study interventions up to 30 days after last dose of study interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completion2 Aug 2028 (estimated)
  4. Study completion2 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692204
Sponsor's protocol ID
TCD23644
Status last verified
Jul 2026
First submitted
24 Jun 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR445877 in people with Gastric Cancer and Oesophageal Carcinoma, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From baseline to the end of study, up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692204.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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