Amivantamab for Colorectal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Carcinoma+1 More
Amivantamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test if a new drug, called amivantamab, can help treat people with metastatic colorectal cancer. Researchers will also look at how safe amivantamab is and what the best dose of amivantamab is when it is combined with other chemotherapy drugs.

Eligible Conditions
  • Colorectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Up to 4 years 3 months

Year 4
Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with AEs
Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with Laboratory Values Abnormalities
Cohorts A, B, C, Ph1b-D, and Ph1b-E: Number of Participants with Vital Signs Abnormalities
Cohorts A, B, and C: Objective Response Rate (ORR)
Cohorts D and E: Number of Participants with Adverse Events (AE)
Cohorts D and E: Number of Participants with Laboratory Values Abnormalities
Cohorts D and E: Number of Participants with Vital Signs Abnormalities
Cohorts D and E: Progression Free Survival (PFS)
Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity
Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT)
Cohorts Ph1b-D, Ph1b-E, D, and E: Clinical Benefit Rate (CBR)
Cohorts Ph1b-D, Ph1b-E, D, and E: Duration of Response (DoR)
Cohorts Ph1b-D, Ph1b-E, D, and E: ORR

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (m...
1 of 3
Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FO...
1 of 3
Cohorts A, B, and C: Amivantamab Monotherapy
1 of 3

Active Control

Experimental Treatment

225 Total Participants · 3 Treatment Groups

Primary Treatment: Amivantamab · No Placebo Group · Phase 1 & 2

Cohorts A, B, and C: Amivantamab Monotherapy
Drug
Experimental Group · 1 Intervention: Amivantamab · Intervention Types: Drug
Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)ActiveComparator Group · 4 Interventions: Leucovorin, Amivantamab, Fluorouracil, Oxaliplatin · Intervention Types: Biological, Drug, Biological, Biological
Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)ActiveComparator Group · 4 Interventions: Irinotecan, Leucovorin, Amivantamab, Fluorouracil · Intervention Types: Biological, Biological, Drug, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years 3 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,326,660 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,638 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease.
Participants must have ECOG PS 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 13th, 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.