Cetuximab for Carcinoma, Hepatocellular

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Hepatocellular+20 More
Cetuximab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Carcinoma, Hepatocellular
  • Malignant Neoplasm of Stomach
  • Oesophageal Squamous Cell Carcinoma
  • Colorectal Carcinoma
  • Adenocarcinoma
  • Liver carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Hepatocellular

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 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

Month 24
Concentrations of SAR444245
Month 24
Incidence of anti-drug antibodies (ADAs) against SAR444245
Month 18
Clinical benefit rate
Duration of response
Progression-free survival
Time to response
Month 9
Objective Response Rate (ORR)
Month 24
Cend of infusion of cetuximab
Ctrough of infusion of cetuximab
Day 30
Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Treatment-emergency adverse events (TEAEs)
Day 90
Assessment of SAR444245 safety profile when combined with other anti-cancer therapies-Serious Adverse Events (SAEs)
Day 90
Assessment of SAR444245 safety profile when combined with other anti-cancer therapies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma, Hepatocellular

Trial Design

7 Treatment Groups

Cohort D1 (Sub-study 04): 3-6L CRC non-MSI-H any RAS
1 of 7
Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1
1 of 7
Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1
1 of 7
Cohort B1 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS ≥1
1 of 7
Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1
1 of 7
Cohort D2 (Sub-study 04): 3-6L CRC non-MSI-H RAS wild type
1 of 7
Cohort B3 (Sub-study 02): 2-4L GC/GEJ Post PD1/PD-L1 non-MSI-H
1 of 7
Experimental Treatment

280 Total Participants · 7 Treatment Groups

Primary Treatment: Cetuximab · No Placebo Group · Phase 2

Cohort D1 (Sub-study 04): 3-6L CRC non-MSI-H any RASExperimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Cohort B2 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS < 1Experimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Cohort A (Sub-study 01): 2-3L ESCC Post PD-1/PD-L1Experimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Cohort B1 (Sub-study 02): 1-3L GC/GEJ PD1/PD-L1 naïve non-MSI-H CPS ≥1Experimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Cohort C (Sub-study 03): 2-3L HCC Post PD-1/PD-L1Experimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Cohort D2 (Sub-study 04): 3-6L CRC non-MSI-H RAS wild typeExperimental Group · 2 Interventions: Cetuximab, THOR-707 · Intervention Types: Drug, Drug
Cohort B3 (Sub-study 02): 2-4L GC/GEJ Post PD1/PD-L1 non-MSI-HExperimental Group · 2 Interventions: THOR-707, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

SanofiLead Sponsor
2,029 Previous Clinical Trials
2,908,089 Total Patients Enrolled
10 Trials studying Carcinoma, Hepatocellular
849 Patients Enrolled for Carcinoma, Hepatocellular
Merck Sharp & Dohme LLCIndustry Sponsor
3,653 Previous Clinical Trials
4,953,327 Total Patients Enrolled
32 Trials studying Carcinoma, Hepatocellular
8,155 Patients Enrolled for Carcinoma, Hepatocellular

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype.
You have histologically or cytologically confirmed advanced unresectable or mCRC.
You must have at least one measurable lesion.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.