Adagrasib for Healthy Subjects

No longer recruiting at 5 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirati Therapeutics Inc.

Disqualifiers: Cardiac disease, Gastrointestinal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 4 periods

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how two versions of the drug adagrasib compare in healthy adults. The goal is to determine if the new high drug load tablets perform as well as the existing ones. Participants should be generally healthy, without major medical conditions, and weigh at least 50 kg (about 110 pounds). The study seeks individuals with no significant health issues affecting the heart, lungs, or digestion. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new formulation.

Do I need to stop my current medications to join the trial?

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

Is there any evidence suggesting that adagrasib is likely to be safe for humans?

Previous studies have shown that adagrasib maintains a consistent safety profile. Research indicates no new safety issues have emerged, and the side effects remain similar to those observed earlier. In trials with cancer patients, some experienced side effects, but these were generally manageable.

This trial is in an early phase, focusing on safety in healthy adults for the first time. Researchers aim to determine how well people can tolerate the drug and identify potential side effects. Since adagrasib is already used in other settings, such as certain cancer treatments, there is some confidence in its safety. However, more data will be collected to ensure its safety in healthy individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Adagrasib because it offers a novel approach to targeting cancer. Unlike most current treatments that work by broadly attacking cancer cells, Adagrasib specifically targets a mutation in the KRAS gene, which is frequently found in various cancers. This precision targeting could potentially lead to fewer side effects and more effective treatment outcomes. Adagrasib's mechanism of action represents a significant advancement compared to traditional chemotherapy and radiation, which can harm healthy cells along with cancerous ones.

What evidence suggests that adagrasib might be an effective treatment?

Research has shown that adagrasib may help treat cancers with a specific change in the KRAS G12C gene. In non-small-cell lung cancer, nearly half of the patients experienced tumor shrinkage, with a confirmed response rate of 42.9%. The treatment also extended the time patients lived without their cancer worsening. Another study found that adagrasib controlled cancer growth in 90% of patients, indicating it can effectively manage the disease. These findings suggest that adagrasib could be a promising option for targeting KRAS G12C mutations in cancer. In this trial, healthy subjects will receive adagrasib in different sequences to further evaluate its effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18.0 to 32.0, weighing at least 50 kg, and without significant health issues or allergies to drugs. Women must not be pregnant or breastfeeding and either not of childbearing potential or using effective non-hormonal contraception.

Inclusion Criteria

I am a healthy adult with no significant medical issues.

Body mass index of 18.0 kg/m2 to 32.0 kg/m^2, inclusive (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m^2 would qualify; a participant with a BMI of 32.5 kg/m^2 or higher would not qualify)

Individuals of childbearing potential (IOCBP) and male participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF

Exclusion Criteria

History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor

I don't have major health issues in areas like metabolism, allergies, skin, kidneys, blood, lungs, heart, stomach, nerves, breathing, hormones, or mental health as judged by a doctor.

I have a history of serious stomach or bowel problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adagrasib reference tablets and high drug load tablets to evaluate bioequivalence

4 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adagrasib

Trial Overview The study is testing whether high drug load tablets of Adagrasib are equivalent in the body to the standard reference tablets when taken by healthy individuals.

How Is the Trial Designed?

Group I: Adagrasib sequence B Experimental Treatment 1 Intervention

Group II: Adagrasib sequence A Experimental Treatment 1 Intervention

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10852394/

Adagrasib in Advanced Solid Tumors Harboring a KRASG12C ... In this study, we observed notable clinical activity with adagrasib in pretreated patients with pancreatic cancer harboring KRASG12C mutations (>80% progressed ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204619

Adagrasib in Non–Small-Cell Lung Cancer Harboring a ... Treatment with adagrasib led to a confirmed objective response rate of 42.9%, a median duration of response of 8.5 months, a median progression- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1556086424009304

OA09.06 Health-Related Quality of Life (HRQoL) Outcomes ... Adagrasib (ADA), a KRAS G12C inhibitor, demonstrated a significant and clinically meaningful benefit in progression-free survival and objective response rate ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00046

Intracranial Efficacy of Adagrasib in Patients From the ... Adagrasib demonstrated an IC objective response rate of 42%, disease control rate of 90%, progression-free survival of 5.4 months, and median ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01149-3/fulltext?rss=yes

Adagrasib for KRAS G12C mutated advanced non-small- ... The primary outcome was progression-free survival, which improved from a median of 3·8 months for patients receiving docetaxel to 5·5 months for ...

6. 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 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/216340Orig1s000MultidisciplineR.pdf

216340Orig1s000 MULTI-DISCIPLINE REVIEW Summary ... ... adagrasib. (600 mg BID) in healthy subjects. Results. 1. Can adagrasib PBPK model describe adagrasib PK in healthy subjects and cancer patients?

8. news.bms.com news.bms.com/news/details/2024/KRAZATI-adagrasib-Demonstrated-Statistically-Significant-Improvement-in-Progression-Free-Survival-in-Patients-with-Pretreated-Locally-Advanced-or-Metastatic-KRASG12C-Mutated-Non-Small-Cell-Lung-Cancer/default.aspx

KRAZATI (adagrasib) Demonstrated Statistically Significant ... No new safety signals were identified for KRAZATI, and the safety data were consistent with the known safety profile. Treatment-related ...

9. aacrjournals.org aacrjournals.org/cancerdiscovery/article/14/6/982/745540/Efficacy-and-Safety-of-Adagrasib-plus-Cetuximab-in

Efficacy and Safety of Adagrasib plus Cetuximab in Patients ... A total of 38 of 94 (40.4%) patients continued adagrasib plus cetuximab beyond disease progression, 10 of 94 (10.6%) patients continued adagrasib only beyond ...

10. journals.lww.com journals.lww.com/md-journal/fulltext/2025/09260/real_world_adverse_event_analysis_of_adagrasib_.29.aspx

Real-world adverse event analysis of Adagrasib: Insights... In conclusion, this study intends to offer a thorough and meticulous analysis of Adagrasib safety profile by leveraging data from the FAERS and ...