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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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:
- •- 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.
排除标准
- •Medical conditions
- •Eastern Cooperative Oncology Group(ECOG)performance status of ≥
- •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.
- •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 ≤
- •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.
研究组 & 干预措施
SAR445877 dose 1
Participants will receive SAR445877 through IV infusion
干预措施: SAR445877 (Drug)
SAR445877 dose 2
Participants will receive SAR445877 through IV infusion
干预措施: SAR445877 (Drug)
结局指标
主要结局
Objective response rate
时间窗: From baseline to the end of study, up to approximately 2 years
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
次要结局
- Number of participants with presence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)(The time from the first dose of study interventions up to 30 days after last dose of study interventions)
- maximum serum concentration (Cmax)(Cycle 1 Day 1 to Day 14(Each cycle is 14 days))
- time to maximum concentration (tmax)(Cycle 1 Day 1 to Day 14(Each cycle is 14 days))
- area under the concentration-time curve over dosing interval (AUCtau)(Cycle 1 Day 1 to Day 14(Each cycle is 14 days))
- End of infusion serum concentration (Cend of infusion)(at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days))
- Percentage of participants with presence of anti-drug antibodies (ADA) against SAR445877(From the first dose of Cycle 1 to 30 days after last dose of study interventions)
- Time to response (TTR)(From baseline to the end of study, up to approximately 2 years)
- Duration of response (DOR)(From baseline to the end of study, up to approximately 2 years)
- Clinical benefit rate(From baseline to the end of study, up to approximately 2 years)
- Progression-free survival (PFS)(From baseline to the end of study, up to approximately 2 years)
- Overall survival (OS)(From baseline to the end of study, up to approximately 2 years)