Long‑term Safety of Adagrasib with Drug Combination in Adults with Solid Tumors

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What is this study about?

The study focuses on patients with a solid tumor, which is a lump of abnormal cells that can grow in any organ or tissue. The investigational medicine is Adagrasib (BMS-986503), which may be given alone or together with other cancer therapies such as pemetrexed, cetuximab and pembrolizumab. Standard supportive drugs that are also used in the study include dexamethasone, taken by mouth, and palonosetron, given through a vein to help prevent nausea.

The main aim of the trial is to assess the long‑term safety of the study drug, meaning how well it is tolerated over time and what side effects may occur. Participants who have already finished earlier studies receive the medication for an extended period, attending regular visits where health checks, blood tests and simple scans are performed. Any unwanted problems, called adverse events, are recorded and evaluated, with particular attention to serious issues that might require medical care.

1 first study visit (baseline)

you will meet the study staff, give informed consent, and undergo baseline assessments such as blood tests, imaging, and a review of your medical history.

the purpose of these assessments is to document your condition before any study medication is started.

2 start oral <b>adagrasib</b>

you will begin taking adagrasib, a film‑coated tablet taken by mouth, at a dose of 9999 mg per day. the exact schedule (for example, once daily) will be provided by the study team.

the tablet is intended to be swallowed with water and should be taken at the same time each day.

3 background medication <b>dexamethasone</b>

in addition to adagrasib, you will receive dexamethasone, an oral steroid, at a dose of 9999 mg. this medication helps reduce inflammation and may lessen certain side effects.

4 intravenous combination therapy (if assigned)

if your treatment plan includes additional cancer medicines, you will receive them by intravenous (iv) infusion, which means the drug is given through a needle into a vein.

the iv medicines may include pemetrexed (dose 9999 mg/ml), cetuximab (dose 9999 mg/m2), and pembrolizumab (dose 9999 mg/ml). each will be given on the days scheduled by the study team.

to help prevent nausea, you will also receive palonosetron by iv at a dose of 9999 µg/ml.

5 regular safety visits

you will return to the clinic regularly (for example, every 4 weeks) for physical examinations, blood tests, and to discuss any side effects you have experienced.

the study staff will record any adverse events, which are any unwanted medical occurrences, whether or not they are related to the study medication.

6 continuation of treatment

you will continue taking the oral medication and receiving any iv medications as long as you remain in the study, up to the planned end date of february 28, 2028, unless a serious side effect requires stopping the treatment.

7 final study visit

at the end of the study, you will have a final assessment that includes a physical exam, laboratory tests, and a summary of any side effects that occurred during the study.

the results of these assessments will be used to evaluate the long‑term safety of adagrasib alone or in combination with the other cancer therapies.

Who Can Join the Study?

  • Must be older than 18 years at the time they sign the consent form.
  • Must sign and date an informed consent document that has been approved by an IRB/IEC (an independent committee that reviews research to protect participants), and be willing and able to attend scheduled visits, follow the treatment schedule, and have any required lab tests.
  • Must be eligible to continue receiving the study medication according to the rules of the original (parent) study.
  • Must not be able to become pregnant, or if they could become pregnant they must have a negative pregnancy test during the study and use effective contraception (reliable birth‑control methods) throughout the study.

Who Cannot Join the Study?

  • If you are not allowed to receive the study medication according to the rules of the earlier related study (parent study), you cannot take part.
  • If you have already finished taking the study drug, if your disease got worse while on a previous study treatment, or if you stopped a previous study treatment because of harmful side effects (toxicity), you cannot join.
  • If you are not experiencing any health improvement (clinical benefit) from the earlier study, or if you have side effects (adverse events (AE)) or unusual test results (lab abnormality) that the doctor believes make participation unsafe, you cannot join.
  • If you have an allergy or a strong allergic reaction (hypersensitivity) to any part of the study drug, you cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Amphia Hospital Breda The Netherlands
Az Maria Middelares Gent Gent Belgium
Metropolitan Hospital Athens Greece
Cocgkg Hczymesruxs Ijihjerdqxscp Ds Cxbgynesxzb Quimper France
Oumnadkb Oxaarcichd Iafcpui Budapest Hungary
Tprwslpjid Csewxr Hwnutbuw Thessaloniki Greece
Ljc Hebeadky Nbfpnismvy Villefranche sur Saône France
Adugtpu Oukgvjjrcgvdcpjftmkegcgxt Sip Lsznj Gmixhih Orbassano Italy
Iuovincz Rmruamghn Pus Lg Swosdw Dvb Teeckf Dfqr Ahsdxgu Ipqx Slrase Meldola Italy
Atizqeziwj Pgewewnd Hnyoplvj Da Mplejsbio Marseille France
Aepcniapc Htkopxam Athens Greece
Bmsferla Ucpjedoiha Hplqlglf Cggnfp Besançon France
Ctlbvw Hihlsjdjebg Rjdwtmyb Udvbopbkzlhft Ds Tyopo Tours France
Mpjxarnv Kcpvrt gsuvg Munich Germany
Ulgsn Dv Regttwrpr Cdrmrdcv Hdw Btovd Saint-Mande France
Awvdnby Ucxxn Slyvkufvp Lslumg Dc Bknomkj Bologna Italy
Nvbsxomvwju Czcczu Iqqidlwec Amsterdam The Netherlands
Gqrhtb Hblibcivpve Uhjxjgxocfdrv Pspep Pfgxrlmwwjy Em Nslfenxdidtk Paris France
Iwecrm Ihxumuqi Fhowggccujhif Okaawfcbuqt Rome Italy
Canhrl Hakxghtdboe Urkhpbzolpgss Dh Puwrlohb Poitiers France
Cwnheq Hridcbrddze Lxjh Soc Pierre Benite France
Adrmpex Oqfzpqnesat Ds Pcvyinm Perugia Italy
Zaozivzzfj Sf Jgngfie Harderwijk The Netherlands
Hxqsikpf Uanbfmbutqhajw Smzdznibwf &toniyg Hugrksn dy Hpgrvbquttb STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.07.2026
France France
Not yet recruiting
01.07.2026
Germany Germany
Not yet recruiting
01.07.2026
Greece Greece
Not yet recruiting
01.07.2026
Hungary Hungary
Not yet recruiting
01.07.2026
Italy Italy
Not yet recruiting
01.07.2026
Portugal Portugal
Not yet recruiting
01.07.2026
The Netherlands The Netherlands
Not yet recruiting
01.07.2026

Trial locations

DEXAMETHASONE is a steroid medication that helps reduce inflammation and swelling. In this study it is given to participants as part of the standard supportive care to help manage side effects from other cancer treatments.

PEMETREXED is a chemotherapy drug that works by stopping cancer cells from making DNA, which they need to grow and divide. In the trial it is used as one of the experimental treatments being tested together with other medicines.

Adagrasib is a targeted therapy that blocks a specific mutation (KRAS G12C) found in some cancers. The study is looking at how safe it is when taken alone or combined with other cancer medicines.

CETUXIMAB is a monoclonal antibody that attaches to a protein called EGFR on the surface of cancer cells. By blocking this protein, it can slow down or stop the growth of the tumor. It is being tested as part of the experimental treatment regimen.

PALONOSETRON is a medication used to prevent nausea and vomiting that often occur with chemotherapy. In this trial it is given to help keep participants comfortable during treatment.

PEMBROLIZUMAB is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a checkpoint that normally keeps the immune response in check, and it is being evaluated as one of the test therapies in the study.

Solid tumor – A solid tumor is a lump of abnormal cells that forms in organs or tissues such as the lung, breast, colon, or bone. It grows by dividing and accumulating more cells, which can enlarge the mass over time. As the tumor expands, it may push against surrounding structures, causing changes in organ function. Cancer cells from the tumor can break away and travel through the bloodstream or lymphatic system to create new growths in other parts of the body. This spread, called metastasis, leads to additional sites of disease that grow in a similar manner.

Trial ID:
2025-524905-34-00
Protocol code:
CA239-0071
NCT ID:
NCT07415031
Trial Phase:
Therapeutic exploratory (Phase II)

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