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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Iqpyzoif Rtndndplw Pjd Lh Stztdn Dth Tugxck Dfqo Auzcbua Iixs Srmycn	Meldola	Italy
Ariggpadvk Pwlujarx Hqtwiyra Dv Msohlzmne	Marseille	France
Uyeybegjrh Hhdfimcjg Pbwnk Scovqcwxnjx Ckcndej Fezb	Paris	France
Hbaxnqzo Vcvm damctdrw	Barcelona	Spain
Cgddyj Odzhx Ltjgnhl	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	02.01.2024
Italy	Not recruiting	02.01.2024
Spain	Not recruiting	02.01.2024

Trial locations

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.

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.

Trial ID:

2023-503223-26-00

Protocol code:

INCB 99280-204

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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