Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

Long-term cancer treatment study for patients who previously received adagrasib.

NCT: NCT07415031 · Status: NOT YET RECRUITING · Phase: Phase 2 · Sponsor: Mirati Therapeutics Inc. · Started: 2026-05-16 · Est. Completion: 2028-02-16

Plain English Summary

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies is a Phase 2 clinical trial sponsored by Mirati Therapeutics Inc. studying Solid Tumors. This study tests continuing treatment with adagrasib, potentially with other cancer drugs, for patients who have already been treated with adagrasib in other studies. It is for patients with advanced solid tumors, including non-small cell lung cancer and colorectal cancer, who have shown benefit from prior adagrasib treatment. Participation involves continuing the study drug treatment and regular monitoring for side effects. Alternative treatments would depend on the specific cancer type and previous treatments received. The trial aims to enroll 170 participants.

Official Summary

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients who are currently in other studies evaluating adagrasib and are eligible to continue treatment. Patients must have shown clinical benefit from their previous adagrasib treatment. Individuals assigned female at birth must not be of childbearing potential or agree to use contraception. Patients who have stopped treatment due to toxicity or lack of benefit in a previous study are not eligible. This trial is studying Solid Tumors, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure the safety of continuing treatment by tracking the number of participants who experience side effects, serious side effects, or side effects that lead to stopping treatmen The specific primary outcome measures are: Number of Participants With Adverse Events (AEs) (Up to 90 days from last dose or study discontinuation); Number of Participants With AEs Leading to Treatment Discontinuation (Up to 90 days from last dose or study discontinuation); Number of Participants With Serious Adverse Events (SAEs) (Up to 90 days from last dose or study discontinuation); Number of Participants With AEs Leading to Death (Up to 90 days from last dose or study discontinuation). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial matters because it offers a long-term treatment option for cancer patients who have responded well to adagrasib, addressing the need for sustained disease control. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Solid Tumors, where improved treatment options are needed.

Investor Insight

This trial signals continued interest in adagrasib for long-term use in solid tumors, suggesting potential for extended patient benefit and market presence if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if continuing adagrasib is the right choice for you based on your previous response and current health. Understand how often you will need to visit the clinic for check-ups and treatment. Discuss any concerns about potential side effects and how they will be managed. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
* Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.

Exclusion Criteria:

* Participant is not eligible for study treatment per the parent study eligibility criteria.
* Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
* Participants not receiving clinical benefit from parent study drug as assessed by the investigator.

Other protocol defined inclusion/exclusion criteria applies.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07415031?

NCT07415031 is a Phase 2 INTERVENTIONAL study titled "A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies." It is currently not yet recruiting and is sponsored by Mirati Therapeutics Inc.. The trial targets enrollment of 170 participants.

What conditions does NCT07415031 study?

This trial investigates treatments for Solid Tumors. The primary condition under study is Solid Tumors.

What treatments are being tested in NCT07415031?

The interventions being studied include: Adagrasib (DRUG), Pembrolizumab (DRUG), Cetuximab (DRUG), Pemetrexed (DRUG), Docetaxel (DRUG). Specified dose on specified days

What does Phase 2 mean for NCT07415031?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07415031?

This trial is currently "Not Yet Recruiting." It started on 2026-05-16. The estimated completion date is 2028-02-16.

Who is sponsoring NCT07415031?

NCT07415031 is sponsored by Mirati Therapeutics Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07415031?

The trial aims to enroll 170 participants. The trial has not yet started recruiting.

How is NCT07415031 designed?

This is a interventional study, uses na allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07415031?

The primary outcome measures are: Number of Participants With Adverse Events (AEs) (Up to 90 days from last dose or study discontinuation); Number of Participants With AEs Leading to Treatment Discontinuation (Up to 90 days from last dose or study discontinuation); Number of Participants With Serious Adverse Events (SAEs) (Up to 90 days from last dose or study discontinuation); Number of Participants With AEs Leading to Death (Up to 90 days from last dose or study discontinuation). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07415031 being conducted?

This trial is being conducted at 20 sites, including Phoenix, Arizona; Bellflower, California; Newark, Delaware; St. Petersburg, Florida and 16 more sites (United States, Canada, Germany).

Where can I find official information about NCT07415031?

The official record for NCT07415031 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07415031. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07415031 testing in simple terms?

This study tests continuing treatment with adagrasib, potentially with other cancer drugs, for patients who have already been treated with adagrasib in other studies. It is for patients with advanced solid tumors, including non-small cell lung cancer and colorectal cancer, who have shown benefit from prior adagrasib treatment.

Why is this trial significant?

This trial matters because it offers a long-term treatment option for cancer patients who have responded well to adagrasib, addressing the need for sustained disease control.

What are the potential risks of participating in NCT07415031?

The main risks involve experiencing side effects from the study drugs, which could range from mild to severe. Some participants may experience side effects that require stopping the study treatment. There is a risk of serious adverse events, including those that could be life-threatening. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07415031?

Ask your doctor if continuing adagrasib is the right choice for you based on your previous response and current health. Understand how often you will need to visit the clinic for check-ups and treatment. Discuss any concerns about potential side effects and how they will be managed. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07415031 signal from an investment perspective?

This trial signals continued interest in adagrasib for long-term use in solid tumors, suggesting potential for extended patient benefit and market presence if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves continuing the study drug treatment and regular monitoring for side effects. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.