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Adagrasib for Healthy Subjects

No longer recruiting at 1 trial location
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Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Mirati Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 a new treatment called Adagrasib, a potential cancer drug, to assess its behavior in the body and its safety and tolerability. The study focuses on healthy participants of Japanese descent to understand how the drug works in this specific group. Healthy adults with no major health issues and both parents of Japanese ethnicity might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

Research has shown that Adagrasib has been tested in various situations and generally has a manageable safety profile. Previous studies found no new safety issues. Some patients experienced side effects like nausea, tiredness, and vomiting, which typically led to temporary treatment breaks rather than complete discontinuation.

A real-world review of side effects identified some serious reactions, such as lung inflammation and pneumonia, though these were rare. Overall, the treatment was well-tolerated, with most side effects being manageable.

These findings suggest that while side effects exist, Adagrasib is relatively safe based on current data. Participants should always discuss potential risks and benefits with their healthcare provider before joining a trial.12345

Why do researchers think this study treatment might be promising?

Adagrasib is unique because it targets a specific mutation in the KRAS gene, which is often involved in the growth of cancer cells. Unlike traditional chemotherapy that affects both healthy and cancerous cells, Adagrasib is designed to specifically inhibit the mutant KRAS protein, potentially leading to fewer side effects and more effective cancer control. Researchers are excited about Adagrasib because it represents a targeted approach, which could provide better outcomes for patients with cancers driven by this mutation.

What evidence suggests that Adagrasib is safe and tolerable for healthy subjects?

Research has shown that adagrasib may help treat cancers with the KRAS G12C mutation. In one study, 35.1% of patients responded positively to the treatment. Another study found that 42.9% of patients responded well, with benefits lasting about 8.5 months. In both studies, patients lived longer without their disease worsening. This evidence suggests that adagrasib could be effective for conditions linked to the KRAS G12C mutation.678910

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 healthy adults of Japanese descent (both parents are ethnically Japanese), aged with a BMI between 18 and 32, and weighing at least 50 kg. Participants must have no significant health issues or abnormal test results.

Inclusion Criteria

Participants must be healthy adults without clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator
Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese)
Participants must have Body mass index of 18.0 kg/m2 to 32.0 kg/m2
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Exclusion Criteria

Other protocol defined Inclusion/Exclusion criteria apply
I do not have any serious ongoing health conditions in major body systems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Adagrasib (BMS-986503)

Single dose

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adagrasib

Trial Overview

The study tests how the body processes a single dose of Adagrasib in healthy Japanese participants. It also looks at safety and tolerability after taking the drug.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AdagrasibExperimental 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

Adagrasib Induces Meaningful Responses in KRAS G12C- ...

The ORR observed with adagrasib monotherapy in the study was 35.1% among 57 evaluable patients. The best objective response was a partial ...

(PDF) Comparative Efficacy of Adagrasib and Sotorasib in ...

TRAEs were reported in 48.7% of patients, with grade 3-4 events in 12.2%, primarily diarrhea and liver enzyme elevations. No treatment-related ...

FDA Approves Adagrasib for KRAS G12C-Mutant Locally ...

The median time to response with adagrasib was 1.4 months (range, 0.9-7.2) and median duration of response was 8.5 months (95% CI, 6.2-13.8). In ...

Adagrasib: a novel inhibitor for KRAS G12C -mutated non- ...

KRYSTAL-I reported an objective response rate of 42.9% with median duration of response of 8.5 months. Treatment-related adverse events were ...

Adagrasib Significantly Improves PFS Vs Chemo in KRAS ...

Data from this confirmatory trial highlighted a statistically significant and clinically meaningful improvement in PFS as well as ORR via ...

Mirati Therapeutics Releases Positive Results of Adagrasib ...

The safety profile of adagrasib was consistent with prior reports, and there were no new safety signals observed. The most frequent treatment of ...

Real-world adverse event analysis of Adagrasib

This retrospective pharmacovigilance study evaluated AEs associated with Adagrasib using data from the FDA adverse event reporting system ...

216340Orig1s000 - accessdata.fda.gov

Adverse reactions requiring dosage interruption in ≥ 2% of patients who received adagrasib included nausea, hepatotoxicity, fatigue, vomiting, ...

A Phase I Study of Adagrasib and Durvalumab ...

Primary Objectives: • To determine the safety and tolerability, and to establish the recommended dose of the adagrasib and durvalumab ...

ADAGRASIB (KRAZATI) Drug Information

In this pooled safety population, the most common Grade 3 or 4 (≥ 2%) laboratory abnormalities were decreased lymphocytes (20%), decreased hemoglobin (7%), ...