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

NCT07686445 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumor (Phase I)
  • RAS Mutation
  • CEACAM5

Interventions

DRUG

Intravenous AN4035

AN4035 is a CAN4035 is a CEACAM5-targeting ADC designed to selectively deliver a proprietary pan-RAS(ON) inhibitor payload to tumor cells.

DRUG

Intravenous AN4035 followed by intravenous EGFR Inhibitor.

AN4035 is a CAN4035 is a CEACAM5-targeting ADC designed to selectively deliver a proprietary pan-RAS(ON) inhibitor payload to tumor cells. EGFR inhibition and RAS signaling is mechanistically complementary, as EGFR functions upstream of RAS activation and may enhance pathway suppression and overcome therapeutic resistance.

Sponsors & Collaborators

  • Adlai Nortye Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-23
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686445 on ClinicalTrials.gov