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NCT05104567 · ClinicalTrials.gov registry record · Phase 2
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
A Phase 2 study of Colorectal Cancer and Gastric Cancer, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT05104567: Completed Phase 2 study of Colorectal Cancer and Gastric Cancer, sponsored by Sanofi.
NCT05104567 is a Phase 2 study of Colorectal Cancer and Gastric Cancer that has completed, run by Sanofi. The registered enrollment target is 138 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05104567, a Phase 2 study of Colorectal Cancer and Gastric Cancer, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study 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 color
Primary Outcome
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as referenc
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cetuximab
- DRUG THOR-707
Study Locations (20)
Other
- Investigational Site Number : 0560002 - Brussels
- Investigational Site Number : 0560003 - Edegem
- Investigational Site Number : 0560001 - Leuven
- Investigational Site Number : 1560002 - Wuhan
- Investigational Site Number : 2500004 - Bordeaux
- Investigational Site Number : 2500006 - Brest
- Investigational Site Number : 2500002 - Paris
- Investigational Site Number : 2500005 - Poitiers
- Investigational Site Number : 2500001 - Villejuif
- Investigational Site Number : 3800003 - Milan
- Investigational Site Number : 3800002 - Milan
- Investigational Site Number : 5280001 - Amsterdam
- Investigational Site Number : 5280003 - Rotterdam
Seoul-teukbyeolsi
- Investigational Site Number : 4100002 - Seoul
- Investigational Site Number : 4100004 - Seoul
California
- City of Hope Site Number : 8400007 - Duarte
Florida
- AdventHealth Orlando Site Number : 8400005 - Orlando
Washington
- Seattle Cancer Care Alliance Site Number : 8400009 - Seattle
Reg Metropolitana de Santiago
- Investigational Site Number : 1520001 - Santiago
Lombardy
- Investigational Site Number : 3800001 - Rozzano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2024-09-09 |
| Phase | Phase 2 |
What the finished NCT05104567 record still lists
NCT05104567 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05104567 names 20 study sites across 7 states, led by Other, Seoul-teukbyeolsi, California.
Frequently Asked Questions
What is clinical trial NCT05104567 about?
NCT05104567 is a clinical study titled "A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)". 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 stu...
What is the current status of trial NCT05104567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2021-12-09. Estimated completion is 2024-09-09.
What conditions does trial NCT05104567 study?
This clinical trial studies the following conditions: Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Oesophageal Squamous Cell Carcinoma, Oesophageal Adenocarcinoma.
What interventions are being tested in trial NCT05104567?
The interventions under investigation include: Pembrolizumab (DRUG), Cetuximab (DRUG), THOR-707 (DRUG).
Who is sponsoring clinical trial NCT05104567?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05104567 being conducted?
This trial has 20 study locations across California, Florida, Washington, Reg Metropolitana de Santiago, Lombardy. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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