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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 7 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05104567
The ClinicalTrials.gov registry entry for NCT05104567 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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