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Study of INCB099280 and Adagrasib for Adults with Advanced Solid Tumors with KRASG12C Mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Advanced Solid Tumors that have a specific genetic change called the KRASG12C mutation. The study will test a combination of two medications: INCB099280 and Adagrasib. These medications are taken as film-coated tablets by mouth. The purpose of the study is to evaluate how safe and tolerable this combination is for patients with these types of tumors.

Participants in the study will receive the combination of INCB099280 and Adagrasib to see how their bodies respond to the treatment. The study will monitor for any side effects and determine the most suitable dose for patients. The trial will also look at how the medications are processed in the body and their effects on the tumors.

The study is designed to help understand the potential benefits and risks of using these medications together for treating Advanced Solid Tumors with the KRASG12C mutation. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the treatment's effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the presence of a KRASG12C mutation in the tumor.
Step 2
Treatment initiation
The treatment involves taking two medications: INCB099280 and Adagrasib. Both are administered orally in the form of film-coated tablets.
The specific dosage and frequency of administration are determined by the study protocol and will be communicated during this phase.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to evaluate the safety and tolerability of the treatment. This includes checking for any side effects and adjusting the dosage if necessary.
The study aims to establish the maximum tolerated dose or identify recommended doses for the combination of the two medications.
Step 4
Response assessment
The effectiveness of the treatment is assessed by measuring the response of the tumor to the medication. This involves imaging tests and other evaluations to determine any changes in tumor size or progression.
Step 5
Follow-up
After completing the treatment phase, follow-up assessments are conducted to monitor long-term effects and overall health status.
These assessments help in understanding the duration of response and any potential late-onset side effects.

Who can join the trial?

12 criteria

Must be able to understand the study information and agree to sign a written consent form.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have an estimated life expectancy of more than 3 months.
Must agree to avoid pregnancy or fathering children during the study and for a specified time after the last dose of the study drug. This includes using highly effective birth control methods.
Must be 18 years of age or older at the time of signing the consent form.
Must have a KRASG12C mutation in their cancer, confirmed by a specific test.
Must have a confirmed diagnosis of a solid tumor that is locally advanced or has spread to other parts of the body.
For Part 1 of the study: Must have experienced disease progression after at least one prior treatment and have received all available standard treatments.
For Part 2 Cohort A: Must have received at least one chemotherapy treatment containing platinum, which may include an anti-PD-1 inhibitor.
For Part 2 Cohort B: Must have received at least one line of systemic therapy.
Must have measurable disease according to RECIST v1.1, which is a set of guidelines to measure how well a tumor responds to treatment.
Must have a known PD-L1 expression level in the tumor, which can be determined by a test at any point during the disease or during the screening process. If unknown, must be willing to provide tumor tissue for testing.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centr Georges Francois Leclerc
Dijon, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

Trial locations

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Investigated drugs

INCB099280
is an investigational medication being studied for its potential to treat advanced solid tumors. It is being tested in combination with another medication to see if it can help stop or slow the growth of cancer cells in patients with a specific genetic mutation known as KRASG12C.
Adagrasib
is a medication that targets the KRASG12C mutation, which is found in some types of cancer. It works by blocking the signals that tell cancer cells to grow and divide. In this study, adagrasib is used in combination with another investigational drug to evaluate their combined effect on tumors with this mutation.

What is already known about the treatment

INCB099280
This medication is administered orally and is currently being studied in clinical trials for its potential use in treating advanced solid tumors with a specific genetic mutation known as KRASG12C. It is still in the early phases of research, and its safety and tolerability are being evaluated. The drug is believed to work by targeting specific pathways involved in cancer cell growth, although its exact mechanism at the molecular level is still under investigation. It falls under the category of investigational cancer therapies.
Adagrasib
This medication is also taken orally and is being tested in combination with INCB099280 for its effectiveness in treating advanced solid tumors with the KRASG12C mutation. Adagrasib is more established in medical literature as a targeted therapy that inhibits the KRASG12C protein, which plays a role in the growth and survival of cancer cells. It is classified as a targeted cancer therapy, specifically designed to interfere with cancer cell signaling pathways.

Investigated diseases

Advanced Solid Tumors Harboring a KRASG12C Mutation – This condition involves a group of cancers that have spread beyond their original site and contain a specific genetic mutation known as KRASG12C. These tumors can occur in various organs and are characterized by uncontrolled cell growth due to the mutation. The KRASG12C mutation affects the KRAS protein, which plays a role in cell signaling pathways that control cell growth and division. As the disease progresses, the tumors may grow larger and spread to other parts of the body. This mutation is a target for specific therapies aimed at inhibiting the abnormal signaling pathways. The progression of these tumors can vary depending on the location and type of the original cancer.