Clinical trials

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Status: Not yet recruiting

A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression

The goal of this clinical trial is to determine whether AN4035 is safe and tolerable in people with advanced or metastatic solid tumors that have Rat Sarcoma oncogene (RAS) mutated solid tumors and high levels of the CEACAM5 protein. RAS genes help control how cells grow and divide. Mutations in RAS can cause cells to grow uncontrollably and contribute to cancer. CEACAM5 is a protein found on the surface of some cancer cells and may serve as a target for AN4035. This is the first time AN4035 is being tested in humans. The study will help identify the best dose(s) for future studies, understand how the body processes the drug, and evaluate whether AN4035 shows signs of fighting cancer. The main questions to answer are: * Which dose(s) of AN4035 are safe and tolerable for participants with RAS-mutated, CEACAM5-positive advanced solid tumors? * What side effects or medical problems do participants experience while receiving AN4035 alone or in combination with cetuximab (Erbitux)? * How does AN4035 move through and affect the body? * Does AN4035 help slow, stop, or shrink tumors? Participants will: * Receive AN4035 by intravenous (IV) infusion every 2 weeks, either alone or in combination with commercially available drug cetuximab. * Visit the clinic regularly for physical examinations, blood tests, safety assessments, and monitoring of their health and cancer status. * Provide blood samples to measure drug levels and help researchers understand how the body processes AN4035. * Undergo scans and other tests to evaluate how their tumors respond to treatment. * Continue treatment until their cancer worsens, they experience unacceptable side effects, choose to leave the study, or their doctor recommends stopping treatment. * Attend follow-up visits after treatment ends and may be contacted periodically to monitor their health and disease status. The study has two parts. In the first part, researchers will gradually increase the dose of AN4035 to determine the highest dose that can be given safely and identify the recommended dose for future studies. This is done for just AN4035 and then for AN4035 + another Anti Cancer agent. In the second part, additional participants with selected tumor types will receive AN4035 at the chosen dose to further evaluate its safety and potential anti-cancer activity.

Participants needed: 228
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Adlai Nortye Biopharma Co., Ltd.Updated: Jul 14, 2026Locations: 2
Eligibility criteria

18 years old at the time of informed consent. [+3]

Are currently enrolled in a clinical trial involving an investigational product... [+23]

Status: Recruiting

An Initial Evaluation of AN8025 in Solid Tumors

The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults \>18 years of age. The main questions to answer: 1. Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors 2. To determine the maximum tolerated of AN8025 for future testing. Participants will visit their study site in 3 week cycles, during which they will be under go treatment with AN8025 and visit their clinical site during each cycle for check ups and testing.

Participants needed: 91
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Adlai Nortye Biopharma Co., Ltd.Updated: Jun 10, 2026Locations: 1
Eligibility criteria

Aged ≥18 years old. [+21]

Are currently enrolled in a clinical study involving an investigational product... [+27]

Status: Recruiting

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 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.

Participants needed: 118
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Adlai Nortye Biopharma Co., Ltd.Updated: Jun 8, 2026Locations: 3
Eligibility criteria

Aged ≥18 years old at the time of informed consent. [+29]

Are currently enrolled in a clinical study involving an investigational product... [+26]

Status: Recruiting

First in Human, Dose Escalation Study of AN4005

Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.

Participants needed: 31
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Adlai Nortye Biopharma Co., Ltd.Updated: Nov 18, 2025Locations: 7
Eligibility criteria

1. Age ≥ 18 years at the time of informed consent and have provided signed infor... [+15]

Have been discontinued treatment due to a Grade 3 or higher immune-related AE (i... [+26]