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 with advanced and metastatic gastrointestinal cancer - ACT16902

Genzyme Europe BV0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Genzyme Europe BV
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Main protocol:
•-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.
•-Capable of giving signed informed consent
•-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 after discontinuing study treatment
•- 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 after
•discontinuing study treatment.
•Sub-study01:
•-Histologically or cytologically confirmed diagnosis of advanced unresectable
•or metastatic esophageal cancer of the squamous cell carcinoma subtype
•-MSI status: Participants must have either unknown MSI status or if MSI status
•is known, participants must have non-MSI-H disease to be eligible.
•-Prior anticancer therapy: Participants should have received at least one but
•no more than 2 prior lines of treatment, including an anti-PD-1/PDL-1
•containing regimen and have progressed after a primary or secondary resistance
•to an anti-PD-1/PDL-1.
•-Sub-study02:
•-Histologically or cytologically confirmed diagnosis of advanced unresectable
•or metastatic gastric cancer or Siewert Type 2 & 3 GEJ.
•-PD-L1 expression using CPS as determined at local laboratory with an approved
•-MSI status: Participants must have MSI status known, determined locally and
•must have non-MSI-H disease to be eligible.
•-HER2/neu status: 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 trastuzumab to be eligible.
•-Prior anticancer therapy: Participants could be anti-PD-1/PDL-1 naïve (cohort
•B1 and B2) or have received an anti-PD-1/PDL-1 before (cohort B3)
•Participants (all sub-studies) must have at least one measurable lesion.
•Mandatory baseline biopsy for the first 20 participants to enroll in substudy01
•and sub-study02 .

排除标准

•- Eastern Cooperative Oncology Group (ECOG) performance status of >=2
•- Predicted life expectancy <=3 months
•- 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
•-History of pneumonitis, interstitial lung disease, HIV infection, uncontrolled
•hepatitis B infection,
•- Antibiotic use (excluding topical antibiotics) <=14 days prior to first dose
•- Severe or unstable cardiac condition within 6 months prior to starting study
•- Active, known, or suspected autoimmune disease that has required systemic
•treatment in the past 2 years
•- Known second malignancy either progressing or requiring active treatment
•last 3 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 vaccination within 28 days of planned treatment
•start. Seasonal flu vaccines that do not contain live virus are permitted

研究者

发起方

Genzyme Europe BV

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