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A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

Primary Purpose

Oesophageal Squamous Cell Carcinoma, Gastric Cancer, Hepatocellular Carcinoma

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

THOR-707

Pembrolizumab

Cetuximab

About this trial

This is an interventional treatment trial for Oesophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Participants with:
- Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype.
- Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
- Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by AASLD criteria in cirrhotic patients.
- Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible.
Participants (all sub-studies) must have at least one measurable lesion.
Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator's discretion for the other cohorts.
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 (for Cohort A, B1, B2, B3, C, and D1) or 60 days (for Cohort D2) [corresponding to the time needed to eliminate any study intervention(s)].
- 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 [corresponding to time needed to eliminate SAR444245] after the last dose of SAR444245.
Capable of giving signed informed consent.

Exclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
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 (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded).
Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP.
Severe or unstable cardiac condition within 6 months prior to starting study treatment.
Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 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 or live attenuated-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1

Cohort B1 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS ≥1

Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1

Cohort B3 (Sub-study 02): 2-4L GC/GEJ Post PD1/PD-L1 non-MSI-H

Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1

Cohort D1 (Sub-study 04): 3-6L CRC non-MSI-H any RAS

Cohort D2 (Sub-study 04): 3-6L CRC non-MSI-H RAS wild type

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

SAR444245 is administered every 3 weeks on Day 1 of each cycle (21 days per cycle) and cetuximab is administered on Day 1, Day 8 and Day 15 of each cycle until progressive disease.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Objective response rate (ORR) defined as proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary Outcome Measures

Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Treatment-emergency adverse events (TEAEs)

Incidence TEAEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Serious Adverse Events (SAEs)

Incidence of SAEs and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

Time to response

Defined as the time from the first administration of investigational medicinal product (IMP) to the first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed and determined by Investigator per RECIST 1.1.

Duration of response

Defined as the time from first tumor assessment at which the overall response was recorded as CR or PR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST 1.1 or death from any cause, whichever occurs first.

Clinical benefit rate

Including confirmed Complete Response (CR) or Partial Response (PR) at any time or stable disease (SD) of at least 6 months (determined by investigator per RECIST 1.1)

Progression-free survival

Defined as the time from the date of first IMP administration to the date of first documented disease progression determine by Investigator as per RECIST 1.1, or death due to any cause, whichever occurs first

Concentrations of SAR444245

Incidence of anti-drug antibodies (ADAs) against SAR444245

Ctrough of infusion of cetuximab

Concentration observed just after treatment administration during repeated dosing

Cend of infusion of cetuximab

Full Information

NCT ID

NCT05104567

First Posted

October 21, 2021

Last Updated

August 7, 2023

Sponsor

Sanofi

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05104567

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 Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

July 26, 2023 (Actual)

Study Completion Date

September 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oesophageal Squamous Cell Carcinoma, Gastric Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Oseophageal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort B1 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS ≥1

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort B3 (Sub-study 02): 2-4L GC/GEJ Post PD1/PD-L1 non-MSI-H

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort D1 (Sub-study 04): 3-6L CRC non-MSI-H any RAS

Arm Type

Experimental

Arm Description

SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Arm Title

Cohort D2 (Sub-study 04): 3-6L CRC non-MSI-H RAS wild type

Arm Type

Experimental

Arm Description

SAR444245 is administered every 3 weeks on Day 1 of each cycle (21 days per cycle) and cetuximab is administered on Day 1, Day 8 and Day 15 of each cycle until progressive disease.

Intervention Type

Drug

Intervention Name(s)

THOR-707

Intervention Description

Solution for infusion: intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

Keytruda®

Intervention Description

Solution for infusion: intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux®

Intervention Description

Solution for infusion: intravenous infusion

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

Baseline to the date of first documentation of progression, assessed approximatively up to 9 months after the first dose of the last patient

Secondary Outcome Measure Information:

Title

Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Treatment-emergency adverse events (TEAEs)

Description

Time Frame

From 1st IMP dose up to 30 days after the last dose of IMP

Title

Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Serious Adverse Events (SAEs)

Description

Time Frame

From 1st IMP dose up to 90 days after the last dose of IMP

Title

Time to response

Description

Time Frame

Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in

Title

Duration of response

Description

Time Frame

Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in

Title

Clinical benefit rate

Description

Including confirmed Complete Response (CR) or Partial Response (PR) at any time or stable disease (SD) of at least 6 months (determined by investigator per RECIST 1.1)

Time Frame

Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in

Title

Progression-free survival

Description

Time Frame

Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in

Title

Concentrations of SAR444245

Time Frame

At Day 1 and Day 2 of Cycle1, at Day 3 and Day 4 of Cycle 1 (only for intensive PK participants), and at Day 1 of Cycle 2-3-4-6-8-10 + every 4th cycle (each cycle is 21 days), maximum up to approximately 24 months

Title

Incidence of anti-drug antibodies (ADAs) against SAR444245

Time Frame

At Day 1 and Day 8 of Cycle1, at Day 1 of Cycle 2-3-4-6-8-10 + every 4th cycle (each cycle is 21 days) and 30 days after last IMP administration, maximum up to approximately 24 months

Title

Ctrough of infusion of cetuximab

Description

Concentration observed just after treatment administration during repeated dosing

Time Frame

Day 1 of Cycle 1-2-3-4-6-8-10 + every 4th cycle (each cycle is 21 days), maximum up to approximately 24 months

Title

Cend of infusion of cetuximab

Time Frame

Day 1 of Cycle 1-2-3-4-6-8-10 + every 4th cycle (each cycle is 21 days), maximum up to approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Participants with: Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype. Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ. Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by AASLD criteria in cirrhotic patients. Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible. Participants (all sub-studies) must have at least one measurable lesion. Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator's discretion for the other cohorts. 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 (for Cohort A, B1, B2, B3, C, and D1) or 60 days (for Cohort D2) [corresponding to the time needed to eliminate any study intervention(s)]. 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 [corresponding to time needed to eliminate SAR444245] after the last dose of SAR444245. Capable of giving signed informed consent. Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of ≥2. 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 (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded). Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP. Severe or unstable cardiac condition within 6 months prior to starting study treatment. Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 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 or live attenuated-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Facility Information:

Facility Name

City of Hope-Site Number:8400007

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

AdventHealth Orlando-Site Number:8400005

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Seattle Cancer Care Alliance-Site Number:8400009

City

Seattle

State/Province

Washington

ZIP/Postal Code

98115

Country

United States

Facility Name

Investigational Site Number :0560002

City

Bruxelles

ZIP/Postal Code

BE-1200

Country

Belgium

Facility Name

Investigational Site Number :0560003

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Investigational Site Number :0560001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number :1520003

City

Santiago

State/Province

Reg Metropolitana De Santiago

ZIP/Postal Code

7500921

Country

Chile

Facility Name

Investigational Site Number :1520001

City

Santiago

State/Province

Reg Metropolitana De Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Investigational Site Number :1520002

City

Temuco

ZIP/Postal Code

4800827

Country

Chile

Facility Name

Investigational Site Number :1560001

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Investigational Site Number :1560002

City

Wuhan

ZIP/Postal Code

430022

Country

China

Facility Name

Investigational Site Number :2500004

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Investigational Site Number :2500006

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Investigational Site Number :2500003

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number :2500002

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Investigational Site Number :2500005

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Investigational Site Number :2500001

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Investigational Site Number :3800001

City

Rozzano

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

Investigational Site Number :3800003

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number :3800002

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Investigational Site Number :3800006

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Investigational Site Number :4100002

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100004

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100001

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100003

City

Seoul

State/Province

Seoul-teukbyeolsi

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Investigational Site Number :5280001

City

Amsterdam

ZIP/Postal Code

1118 HV

Country

Netherlands

Facility Name

Investigational Site Number :5280003

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Investigational Site Number :7240002

City

Barcelona

State/Province

Barcelona [Barcelona]

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number :7240006

City

Barcelona

State/Province

Barcelona [Barcelona]

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number :7240005

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Investigational Site Number :7240003

City

Madrid / Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number :7240004

City

Madrid / Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28050

Country

Spain

Facility Name

Investigational Site Number :7240101

City

Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28027

Country

Spain

Facility Name

Investigational Site Number :7240001

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

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A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

Oesophageal Squamous Cell Carcinoma, Gastric Cancer, Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial