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Monoclonal Antibodies

INCB099280 + Adagrasib for Solid Tumors

Phase 1

Waitlist Available

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

Must not have

Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease

History or evidence of interstitial lung disease, including noninfectious pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases needing treatment or a condition affecting the lining of my brain.

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I have a history of lung conditions not caused by infections.

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I have had chest radiation of more than 30 Gy in the last 6 months.

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I am on high-dose steroids or other medications for an autoimmune disease.

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I am currently on medication for an infection.

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I have had an organ or stem cell transplant.

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I have previously been treated with a drug targeting KRASG12C.

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I am not taking probiotics during the study.

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I have an immune system disorder or take more than 10 mg of steroids daily.

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I still have side effects from previous treatments that haven't fully healed.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

INCB099280 and adagrasib plasma concentrations.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB099280

2024

Completed Phase 1

~10

0 / 18Eligibility criteria met