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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 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

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

55,170 Total Patients Enrolled

Mirati Therapeutics Inc.Industry Sponsor

70 Previous Clinical Trials

8,080 Total Patients Enrolled

Incyte Medical MonitorStudy DirectorIncyte Corporation

23 Previous Clinical Trials

4,947 Total Patients Enrolled

Frequently Asked Questions

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

Is this trial currently accepting participants?

"According to the information on clinicaltrials.gov, this particular trial is not recruiting patients presently as it was last edited on September 8th 2023 after its original posting date of October 20th 2023. Fortunately, there are over two thousand six hundred and ninety-six other medical studies that are currently searching for participants."

Answered by AI

Has the FDA sanctioned Part 2: Dose Expansion?

"Due to the limited amount of data available on Part 2: Dose Expansion, our team at Power assigned it a safety rating of 1."

Answered by AI

What objectives is the clinical trial aiming to fulfill?

"This clinical trial intends to evaluate the Dose Limiting Toxicities (DLTs) of a treatment, observed over a period of 2 years and 90 days. Secondary goals include assessing Disease Control Rate (DCR), Duration of Response (DOR), as well as INCB099280 and adagrasib plasma concentrations via noncompartmental PK methods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

2023. "A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039384.

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