Clinical trial for Advanced or Metastatic Colorectal Cancer
Official title A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05379595
What this study is testing
What is Amivantamab IV?
An investigational intravenous infusion being studied as a potential treatment for advanced or metastatic colorectal cancer. is designed to target both EGFR and MET receptors to help the immune system attack cancer cells.
Also referred to as RYBREVANT, JNJ-61186372.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how well amivantamab works against tumors by itself, find a safe dose when it is added to standard chemotherapy, and check the safety of the combination.
- Who it's for
- Adults who have advanced or metastatic colorectal cancer.
- What's involved
- Participants receive infusions of amivantamab, either by itself or together with their usual chemotherapy, and undergo regular clinic visits and safety tests.
- Time commitment
- The trial runs for several months, with multiple visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon...
- Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic...
- Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and...
- Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be...
- For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease.
You likely can't join if
- Cohorts A, B, C, Ph1b-D, D, Ph1b-E, and E: Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral...
- Participant with symptomatic or untreated brain metastasis
- History or known presence of leptomeningeal disease
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example...
See the full eligibility criteria
- Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
- Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting.
- Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the...
- Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be eligible for treatment with mFOLFOX6 according to local regulatory...
- For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy. Biopsies are required if clinically feasible for participants in Ph1b-D, Ph1b-E, and Cohort F.
- A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests...
- Cohorts A, B, C, Ph1b-D, D, Ph1b-E, and E: Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog...
- Participant with symptomatic or untreated brain metastasis
- History or known presence of leptomeningeal disease
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Ann Arbor, Michigan, United States
- Hattiesburg, Mississippi, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Anderlecht, Belgium
- Brussels, Belgium
- Edegem, Belgium
- Leuven, Belgium
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Guangzhou, China
- Hangzhou, China
- Wuhan, China
- Hamburg, Germany
- Munich, Germany
- Milan, Italy
- Pisa, Italy
- Kuala Lumpur, Malaysia
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Ann Arbor, Michigan, United States; Hattiesburg, Mississippi, United States; New York, New York, United States; Nashville, Tennessee, United States; Houston, Texas, United States and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.