170 Participants NeededMy employer runs this trial

Adagrasib + Other Treatments for Solid Tumors

Recruiting at 114 trial locations
BC
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mirati Therapeutics Inc.
Must be taking: Adagrasib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the cancer drug adagrasib in individuals with solid tumors, such as non-small cell lung cancer and colorectal cancer. Researchers aim to evaluate the effectiveness of adagrasib alone or in combination with other treatments. Those who participated in a related study and continue to benefit from the treatment may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adagrasib, the treatment under study in this trial, generally has a manageable safety profile. In earlier studies, patients with advanced solid tumors who took adagrasib mostly experienced mild to moderate side effects. Common side effects included tiredness, nausea, and diarrhea, but these were usually not severe.

One study specifically found that for patients with KRAS G12C mutations, the side effects of adagrasib were manageable. While side effects occurred, they were not serious enough to outweigh the potential benefits, suggesting that many patients can tolerate adagrasib well.

This trial is in phase 2, indicating that enough safety information has been gathered from earlier studies to continue testing in a larger group. Overall, existing data supports that adagrasib is reasonably safe for use in this clinical research.12345

Why are researchers excited about this trial's treatments?

Adagrasib is unique because it targets a specific mutation in the KRAS gene, which is a common driver in many solid tumors but has been notoriously difficult to treat. Unlike traditional chemotherapy that indiscriminately attacks rapidly dividing cells, Adagrasib precisely inhibits the mutant KRAS protein, potentially leading to better outcomes with fewer side effects. Researchers are excited about Adagrasib because it offers a targeted approach that could be more effective and safer for patients with specific genetic profiles compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that adagrasib effectively treats solid tumors with the KRAS G12C mutation. Patients with this mutation have experienced significant survival benefits. Specifically, the average overall survival was about 14 months, and the time during which the cancer did not worsen was around 7 months. Tumor shrinkage or stabilization rates were also promising. In some patients, the response rate to adagrasib alone was 22%. In this trial, some participants will receive adagrasib alone, while others will receive it combined with cetuximab. Previous studies have shown that this combination increases the response rate to 39%. This suggests that adagrasib can be a strong option for people with these types of tumors.12367

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors, like lung or colorectal cancer, who were already taking adagrasib (alone or with other drugs) in a previous study and are still benefiting from treatment. Participants must meet the original study's requirements and follow birth control rules if needed.

Inclusion Criteria

* Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
I was assigned female at birth and cannot become pregnant, or I use birth control as required.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adagrasib as monotherapy or in combination with other cancer therapies

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension

Participants continue to receive adagrasib treatment as part of the rollover trial

Indefinite

What Are the Treatments Tested in This Trial?

Interventions

  • Adagrasib

Trial Overview

The trial continues to provide adagrasib alone or combined with other cancer treatments such as pembrolizumab, docetaxel, irinotecan, cetuximab, pemetrexed, leucovorin, oxaliplatin, or fluorouracil. It is open-label and only includes patients from earlier related studies.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Group I: Arm C4Experimental Treatment3 Interventions
Group II: Arm C3Experimental Treatment3 Interventions
Group III: Arm C2Experimental Treatment1 Intervention
Group IV: Arm C1Experimental Treatment1 Intervention
Group V: Arm B4Experimental Treatment3 Interventions
Group VI: Arm B3Experimental Treatment2 Interventions
Group VII: Arm B2Experimental Treatment2 Interventions
Group VIII: Arm B1Experimental Treatment2 Interventions
Group IX: Arm A2Experimental Treatment1 Intervention
Group X: Arm A1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials
73
Recruited
8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Citations

Clinical outcomes and safety profile of adagrasib in KRAS ...

Adagrasib demonstrated robust efficacy in KRAS G12C-mutant solid tumors, with significant survival benefits and high response rates.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40844328/

Clinical Outcomes and Safety Profile of Adagrasib in KRAS ...

Adagrasib showed a median overall survival (OS) of 14.74 months (95% CI: 12.06-17.42, I²=40.4%) and progression-free survival (PFS) of 6.80 ...

83P Efficacy and safety of KRAS G12C inhibitors across ...

This systematic review and meta-analysis aimed to evaluate the pooled efficacy outcomes and adverse event profiles of KRAS G12C inhibitors in solid tumors.

Adagrasib in Non–Small-Cell Lung Cancer Harboring a ...

Adagrasib has been shown in patients with KRAS G12C-mutated solid tumors, including colorectal, pancreatic, and biliary tract cancers.

KRAZATI (adagrasib) Demonstrated Statistically Significant ...

First presentation of data from Phase 3 KRYSTAL-12 study showed statistically significant and clinically meaningful improvement in ...

Clinical Outcomes and Safety Profile of Adagrasib...

Adagrasib showed a median overall survival (OS) of 14.74 months (95% CI: 12.06-17.42, I²=40.4%) and progression-free survival (PFS) of 6.80 months (95% CI: 6.14 ...

Adagrasib in Advanced Solid Tumors Harboring a KRASG12C ...

Adagrasib demonstrated an encouraging objective response rate of 35.1% in a biomarker-selected population who have declined or have no available standard-of- ...