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Monoclonal Antibodies

INCB099280 + Adagrasib for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Only participants with NSCLC will be enrolled into Part 2 Cohort A
Only participants with CRC will be enrolled into Part 2 Cohort B
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial studies if a combination of two medicines is safe and tolerable, and if it should be used to treat certain diseases.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called KRASG12C. Participants must have certain types of cancer like NSCLC or CRC, depending on the study part they're in, and should have tried some treatments already without success. They need to be relatively healthy otherwise, with an expected lifespan over 3 months and no serious recent infections or other cancers.Check my eligibility
What is being tested?
The trial is testing how safe it is to use INCB099280 together with adagrasib on patients and figuring out the right doses. Researchers want to see if this combo can help people whose tumors haven't responded well to previous treatments.See study design
What are the potential side effects?
While not specified here, common side effects for cancer drugs like INCB099280 and adagrasib may include nausea, fatigue, diarrhea, liver issues, skin reactions, and potential risks for infection due to weakened immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have non-small cell lung cancer and am eligible for Part 2 Cohort A.
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I have colorectal cancer and am enrolling in Part 2 Cohort B.
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My cancer is confirmed to be advanced or has spread to other parts.
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My condition worsened after at least one treatment.
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I have colorectal cancer and have been treated with specific chemotherapy and targeted therapy.
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My cancer has a KRASG12C mutation.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
INCB099280 and adagrasib plasma concentrations.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions
Up to 80 participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort A: previously treated KRASG12C mutated non-small cell lung cancer (NSCLC) Cohort B: previously treated KRASG12C-mutated colorectal cancer (CRC). Up to 3 doses may be selected from Part 1: Dose Finding for the Part 2: Dose Expansion.
Group II: Part 1: Dose FindingExperimental Treatment2 Interventions
INCB099280 administered in combination with adagrasib in participants with previously treated KRAS glutamine to cysteine mutation at codon 12 (KRASG12C) mutant advanced solid tumors, will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
368 Previous Clinical Trials
55,334 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
7,938 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
25 Previous Clinical Trials
5,100 Total Patients Enrolled
~83 spots leftby Nov 2025
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