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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAR445877

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: SAR445877 dose 1Experimental treatment 1 intervention
Group B: SAR445877 dose 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
From baseline to the end of study, up to approximately 2 years

Secondary outcomes

1

maximum serum concentration (Cmax)

Time frame
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
2

time to maximum concentration (tmax)

Time frame
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
3

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

Time frame
Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
4

End of infusion serum concentration (Cend of infusion)

Time frame
at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.