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Monoclonal Antibodies

Amivantamab + Chemotherapy for Colorectal Cancer (OrigAMI-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 3 months
Awards & highlights

OrigAMI-1 Trial 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.

Who is the study for?
This trial is for adults with advanced colorectal cancer that can't be removed by surgery or has spread. They must have a specific performance status, agree to a tumor biopsy, and not be pregnant. People with certain genetic mutations or brain metastasis are excluded.Check my eligibility
What is being tested?
The study tests amivantamab alone and alongside standard chemotherapy (Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan) in patients with metastatic colorectal cancer. It aims to find the safest dose when combined with chemo and measure its effectiveness against tumors.See study design
What are the potential side effects?
Amivantamab may cause side effects like infusion reactions (symptoms at the site of injection), skin rash, fatigue, and possibly affect liver function. Standard chemotherapy can lead to nausea, hair loss, nerve damage, diarrhea, and low blood cell counts.

OrigAMI-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have been diagnosed with a type of colon or rectal cancer that cannot be removed by surgery.
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I am not pregnant, breastfeeding, or planning to become pregnant and agree to regular pregnancy tests.
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My cancer can be measured or seen on scans.
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I agree to have a biopsy of my tumor as required by the study.

OrigAMI-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 3 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
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
+3 more
Secondary outcome measures
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
+4 more

OrigAMI-1 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cohorts A, B, and C: Amivantamab MonotherapyExperimental Treatment1 Intervention
Participants with left-sided colorectal cancer (CRC) in Cohort A (no prior anti-epidermal growth factor receptor [EGFR] therapy) and in Cohort B (post anti-EGFR therapy), and right-sided CRC in Cohort C (with or without anti-EGFR therapy), will be administered intravenous (IV) infusion of amivantamab 1050 milligrams (mg) if body weight (BW) is less than (<) 80 kilograms (kg) or 1400 mg if BW is greater than or equal to (>=) 80 kg, as monotherapy on Days 1 and 15 of Cycle 2 (28-days cycle).
Group II: Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)Active Control4 Interventions
Participants who are anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab along with FOLFIRI SOC chemotherapy on Days -1, -2, and 8 of Cycle 1 and Days 1 and 15 of Cycle 2 in Ph1b-E. For Cohort E, RP2CD determined in Ph1b-E will be administered.
Group III: Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)Active Control4 Interventions
Participants who are anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab 1050 or 700 mg (dose level 0 [DL0]) if BW is <80 kg, or 1400 or 1050 mg (dose de-escalation [DL-1]) if BW is >= 80 kg, on Days -1, -2, 8 and 22 of Cycle 1 and along with mFOLFOX6 SOC chemotherapy on Days 1 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 (each cycle of 28 days) in Phase 1b dose confirmation Cohort (Cohort Ph1b-D). Participant in Phase 2 Cohort (Cohort D) will receive recommended Phase 2 combination dose (RP2CD) of amivantamab along with mFOLFOX6 SOC chemotherapy determined in Cohort Ph1b-D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amivantamab
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,384,061 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,680 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05379595 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI), Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6), Cohorts A, B, and C: Amivantamab Monotherapy
Colorectal Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT05379595 — Phase 1 & 2
Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05379595 — Phase 1 & 2

Frequently Asked Questions

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

Are there numerous medical facilities in the US conducting this research study?

"This study is recruiting participants from 21 different healthcare facilities, including the Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center in New york City, Princess Margaret Cancer Centre University Health Network in Toronto, and Stephenson Cancer Center of Oklahoma City."

Answered by AI

What objectives is this medical research attempting to meet?

"This trial, which will be monitored for a span of up to 4 years and 3 months, seeks to measure the incidence of Adverse Events among participants. Secondary objectives include tracking vital signs abnormalities (temperature, heart rate etc.), laboratory value aberrations (serum chemistry etc.) as well as grading severity levels of adverse effects according to NCI CTCAE's version 5.0 scale that ranges from mild (Grade 1) to death-related occurrences (Grade 5)."

Answered by AI

Is enrollment still open for this medical experiment?

"As evidenced by clinicaltrials.gov, this research endeavour is actively seeking participants since its inception on July 29th 2022 and last update November 3rd 2022."

Answered by AI

What is the aggregate count of participants in this research?

"To complete this clinical trial, 225 individuals fitting the established inclusion criteria must participate. Potential enrollees can join at Herbert Irving Comprehensive Cancer Center and Columbia University Medical Center in New york City or Princess Margaret Cancer Centre University Health Network in Toronto."

Answered by AI

Who else is applying?

What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~145 spots leftby Apr 2027