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NCT07252479 · ClinicalTrials.gov registry record · Phase 1

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

A Phase 1 study of RAS Mutation and Solid Tumors (Phase 1), sponsored by Adlai Nortye Biopharma Co..

Recruiting
Registry status
Phase 1
Development phase
91
Enrollment target
2
Study locations

NCT07252479: Recruiting Phase 1 study of RAS Mutation and Solid Tumors (Phase 1), sponsored by Adlai Nortye Biopharma Co..

NCT07252479 is a Phase 1 study of RAS Mutation and Solid Tumors (Phase 1) that is actively recruiting participants, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 91 participants, below the 341-participant average among 4 other RAS Mutation trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07252479, a Phase 1 study of RAS Mutation and Solid Tumors (Phase 1), is actively recruiting participants, sponsored by Adlai Nortye Biopharma Co..

RECRUITING
Registry status
Phase 1
Development phase
91 participants
Enrollment target
2
Study locations

Study Summary

The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are: Which dose(s) of AN9025 are safe and tolerable for use in evaluating anti-tumor activity in participants with Rat Sarcoma oncogene (RAS) mutated solid tumors? What medical problems do participants have when taking AN9025? Participants will: Take AN9025 by mouth every day until their disease progresses, they experience severe ill side effects from taking the drug, or withdraw from the study due to their own choice or as recommended by their physician. Visit the clinic 3-4 times during the first 21 days of treatment for study testing, blood draws and tumor tissue sample collection (if needed). The blood draws will be used to check drug levels in the participants blood for research purposes. Visit the clinic every 21 days for checkups and tests and monitoring of participant progress. Return to the clinic at 14 and 30 days after AN9025 treatment is stopped. Participants will be contacted every 3 months to check on the participants disease status and general well being. Participants may also partake in a food effect study, where the effect of eating is studied to see if there is any effect on AN9025 in the body.

Primary Outcome

• Incidence, nature, and severity of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Conditions Studied

RAS Mutation Solid Tumors (Phase 1)

Interventions

  • DRUG AN9025 oral capsule

Study Locations (2)

Florida

  • Sarah Cannon Research Institute at Florida Cancer Specialists - Orlando

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2026-01-28
Est. Completion 2028-06-01
Phase Phase 1
Adlai Nortye Biopharma Co.

6 total trials

What NCT07252479 shows while recruiting

NCT07252479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 341-participant average among 4 other RAS Mutation trials with a reported enrollment target (73% lower).

The record links to 2 conditions, with RAS Mutation appearing as the primary indexed condition, and to 1 intervention - of which AN9025 oral capsule is the first listed.

NCT07252479 reports a single indexed study location in Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT07252479 about?

NCT07252479 is a clinical study titled "Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations". The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are: Which dos...

What is the current status of trial NCT07252479?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2026-01-28. Estimated completion is 2028-06-01.

What conditions does trial NCT07252479 study?

This clinical trial studies the following conditions: RAS Mutation, Solid Tumors (Phase 1).

What interventions are being tested in trial NCT07252479?

The interventions under investigation include: AN9025 oral capsule (DRUG).

Who is sponsoring clinical trial NCT07252479?

This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07252479 being conducted?

This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT07252479

Source: ClinicalTrials.gov NCT07252479, the US trial registry maintained by the National Library of Medicine. NCT07252479 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.