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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Adlai Nortye Biopharma Co., Ltd.
Study ID
NCT07252479
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • RAS Mutation
  • Solid Tumors (Phase 1)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AN9025 oral capsule — DRUG
    AN9025 is a novel, oral, small molecule pan-RAS (ON) inhibitor that binds cyclophilin A (CypA) with a slow dissociation rate, forming a tri-complex with guanosine triphosphate (GTP) bound state of both mutant and wild-type RAS proteins. AN9025 exhibits potent anti-proliferative activity in RAS-addicted cancer cell lines, demonstrates favorable pharmacokinetics (PK), pharmacodynamics and an acceptable tolerability profile in vivo.

Study Details

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 or once a week 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.

Key Dates

Start date
Jan 28, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
118 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AN9025 Treatment
    Oral administration of AN9025 capsules

Primary Outcome Measure

• Nature and frequency of dose limiting toxicities (DLTs) [ Time Frame: 21 days after first dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827
Lead Study Coordinator
[email protected]
904-380-2410
H. Lee Moffit Cancer Center and Research Institute Hospital, Inc.TampaFlorida33612-9497
Kevin Executive Director
[email protected]
848 230-7430
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Hong, MD
[email protected]
8776326789

Find similar trials in Orlando, FL

By research site
Sarah Cannon Research Institute at Florida Cancer Specialists· Orlando, FLH. Lee Moffit Cancer Center and Research Institute Hospital, Inc.· Tampa, FLUniversity of Texas MD Anderson Cancer Center· Houston, TX

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