Adagrasib for Healthy Subjects
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of Adagrasib (BMS-986503)
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the single dose
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mirati Therapeutics Inc.
Lead Sponsor
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.
targetedonc.com
targetedonc.com/view/adagrasib-induces-meaningful-responses-in-kras-g12c-mutated-solid-tumorsAdagrasib 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 ...
2.
researchgate.net
researchgate.net/publication/385446168_Comparative_Efficacy_of_Adagrasib_and_Sotorasib_in_KRAS_G12C-Mutant_NSCLC_Insights_from_Pivotal_Trials(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 ...
3.
targetedonc.com
targetedonc.com/view/fda-approves-adagrasib-for-kras-g12c-mutant-locally-advanced-metastatic-nsclcFDA 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 ...
4.
pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/adagrasib-a-novel-inhibitor-for-krassupg12csup-mutated-non-small-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 ...
5.
cancernetwork.com
cancernetwork.com/view/adagrasib-significantly-improves-pfs-vs-chemo-in-kras-g12c-mutated-nsclcAdagrasib 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 ...
6.
pharmacytimes.com
pharmacytimes.com/view/mirati-therapeutics-releases-positive-results-of-adagrasib-for-treatment-of-nsclcMirati 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 ...
7.
researchgate.net
researchgate.net/publication/396038954_Real-world_adverse_event_analysis_of_Adagrasib_Insights_from_the_FAERS_databaseReal-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, ...
9.
trial.medpath.com
trial.medpath.com/clinical-trial/186550bb457888cc/nct05848843-adagrasib-durvalumab-advanced-lung-gastrointestinal-cancersA 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%), ...
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