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EGFR Inhibitor

SAR444245 + Anticancer Therapies for Gastrointestinal Cancer

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial is a phase 2 study investigating the efficacy of SAR444245 in combination with other cancer treatments for patients with advanced gastrointestinal cancer. The study is composed of four sub-studies, each investigating the combination of SAR444245 with a different treatment for a different type of gastrointestinal cancer. The primary outcome measure for each sub-study is the percentage of patients experiencing an objective response.

Who is the study for?
Adults with advanced gastrointestinal cancers, including esophageal squamous cell carcinoma, gastric cancer or gastro-esophageal junction adenocarcinoma, hepatocellular carcinoma (HCC), and metastatic colorectal cancer (non-MSI-H). Participants must have measurable lesions and agree to contraception. Excluded are those with poor performance status, organ function issues, brain metastases, recent major surgery or therapy, autoimmune diseases requiring treatment in the past 2 years.Check my eligibility
What is being tested?
The trial is testing SAR444245 (THOR-707) combined with pembrolizumab or cetuximab in various cohorts of gastrointestinal cancer patients. It aims to see if these combinations can increase the percentage of patients who respond to treatment. The study involves multiple sub-studies targeting different types of tumors.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab or cetuximab such as inflammation in organs; infusion reactions; fatigue; skin rash; digestive issues like diarrhea; liver enzyme elevation could occur from THOR-707.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old or the legal age in my country.
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My cancer is advanced, cannot be surgically removed, and is in the stomach or gastroesophageal junction.
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My colorectal cancer is advanced, cannot be surgically removed, and is not MSI-H.
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My liver cancer is advanced and cannot be removed by surgery.
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My esophageal cancer is advanced, cannot be surgically removed, and is a type called squamous cell.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Serious Adverse Events (SAEs)
Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Treatment-emergency adverse events (TEAEs)
Cend of infusion of cetuximab
+7 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort D2 (Sub-study 04): 3-6L CRC non-MSI-H RAS wild typeExperimental Treatment2 Interventions
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.
Group II: Cohort D1 (Sub-study 04): 3-6L CRC non-MSI-H any RASExperimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group III: Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1Experimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group IV: Cohort B3 (Sub-study 02): 2-4L GC/GEJ Post PD1/PD-L1 non-MSI-HExperimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group V: Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1Experimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group VI: Cohort B1 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS ≥1Experimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Group VII: Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1Experimental Treatment2 Interventions
SAR444245 and pembrolizumab are administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,342 Total Patients Enrolled
2 Trials studying Liver Cancer
37 Patients Enrolled for Liver Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,415 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer

Media Library

Cetuximab (EGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05104567 — Phase 2
Liver Cancer Research Study Groups: Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1, Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1, Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1, Cohort B1 (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 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
Liver Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05104567 — Phase 2
Cetuximab (EGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104567 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many research facilities can patients participate in this trial?

"Patients can be enrolled at locations such as Advent Health Medical Group - West Florida-Site Number:8400005 in Tampa, Florida, AdventHealth Orlando-Site Number:8400005 in Orlando, New york, and Columbia University Medical Center-Site Number:8400003 in New York, Massachusetts. There are 9 other sites where patients can enroll."

Answered by AI

Has Cetuximab been cleared by the FDA?

"Cetuximab has undergone some safety testing, but there is no evidence yet of its efficacy. Our team rates it a 2."

Answered by AI

How many people will be taking part in this experiment at most?

"This study is not recruiting at the moment. The posting date was December 9th, 2021 with the most recent update on October 31st, 2022. If you are looking for other trials, 3835 studies related to carcinoma and hepatocellular are actively searching for participants while 1123 Cetuximab studies are also open."

Answered by AI

For what purpose is Cetuximab usually employed?

"Cetuximab, while most often used to treat melanoma, can also be employed as a treatment for microsatellite instability high, high risk of recurrence, and intolerance to irinotecan."

Answered by AI

Is this a new type of clinical trial?

"Cetuximab has been under clinical research since 2005. The first trial, which was completed that year and sponsored by Bristol-Myers Squibb, involved 154 patients. After the successful initial study, cetuximab received its Phase 2 drug approval in 2005. As of now, there are 1123 live studies involving Cetuximab across 3235 cities and 65 countries."

Answered by AI

Do we have any other data on Cetuximab's effects?

"Cetuximab was first studied in the year 2005 at Mamie McFaddin Ward Cancer Center. 615 clinical trials have completed since then with 1123 more currently underway. A large number of these ongoing trials are based in Tampa, Florida."

Answered by AI

Can more people join this clinical trial?

"The information available on clinicaltrials.gov suggests that this particular trial is not presently looking for patients. This trial was initially posted on December 9th, 2021 and updated as recently as October 31st, 2022. There are 4,958 other trials in which you might be able to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
2021. "A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05104567.
All > Colorectal Cancer Los Angeles
~41 spots leftby Apr 2025
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