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Brief Title: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
Official Title: 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
Study ID: NCT05104567
Brief Summary: The study is 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 aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens. Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens. Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).
Detailed Description: The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period \[max 35 cycles {cohort A; B1,B2, B3, C and D1} = 735 days or until PD {cohort D2}\], an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Site Number : 8400007, Duarte, California, United States
AdventHealth Orlando Site Number : 8400005, Orlando, Florida, United States
Seattle Cancer Care Alliance Site Number : 8400009, Seattle, Washington, United States
Investigational Site Number : 0560002, Bruxelles, , Belgium
Investigational Site Number : 0560003, Edegem, , Belgium
Investigational Site Number : 0560001, Leuven, , Belgium
Investigational Site Number : 1520001, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1560002, Wuhan, , China
Investigational Site Number : 2500004, Bordeaux, , France
Investigational Site Number : 2500006, Brest, , France
Investigational Site Number : 2500002, Paris, , France
Investigational Site Number : 2500005, Poitiers, , France
Investigational Site Number : 2500001, Villejuif, , France
Investigational Site Number : 3800001, Rozzano, Lombardia, Italy
Investigational Site Number : 3800003, Milano, , Italy
Investigational Site Number : 3800002, Milano, , Italy
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 5280001, Amsterdam, , Netherlands
Investigational Site Number : 5280003, Rotterdam, , Netherlands
Investigational Site Number : 7240002, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005, Santander, Cantabria, Spain
Investigational Site Number : 7240003, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240004, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240101, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240001, Pamplona, Navarra, Spain