AN4005 for Advanced Cancer

Recruiting at 6 trial locations

Overseen By Kirsten Lee

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adlai Nortye Biopharma Co., Ltd.

Must not be taking: Immunosuppressants, Steroids, Antibiotics, others

Disqualifiers: Autoimmune disease, Cardiovascular impairment, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AN4005, in patients with advanced tumors. It aims to find the highest safe dose by adjusting the amount given over time.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain drugs that affect liver enzymes (CYP3A4, UGT, P-gP) two weeks before and during the trial. It's best to discuss your current medications with the study team.

Research Team

Kevin Dryer

Principal Investigator

Adlai Nortye USA Inc

Eligibility Criteria

Adults with advanced solid tumors or relapsed/refractory lymphoma, who have no standard treatment options left. They must be expected to live at least 3 months, have a performance status of 0 or 1 (able to carry out daily activities), and meet certain organ function criteria. Pregnant or breastfeeding women are excluded, as well as those with recent infections, vaccinations, other treatments, or severe allergies.

Inclusion Criteria

Provided archival tumor tissue sample or newly obtained biopsy

I have provided a recent biopsy of my tumor, not previously treated with radiation.

Standard treatments are not suitable or tolerable for me.

Exclusion Criteria

Currently participating in another investigational study within 4 weeks or less than 5 half-lives

I have not had another cancer in the last 2 years, with some exceptions.

I have not taken any antibiotics by mouth or IV in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of AN4005 to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

Up to 28 days per dose level

Multiple visits for dose escalation and safety monitoring

Treatment

Participants receive AN4005 at the determined MTD/RP2D

Up to 1 year

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 90 days

Treatment Details

Interventions

• AN4005

Trial Overview AN4005 is being tested in various doses on patients with advanced tumors to assess its safety and tolerability. This first-in-human study uses a '3 + 3 design' for dose escalation to find the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D).

Participant Groups

Group I: AN4005 food effect Active Control 1 Intervention

The effect of a high-fat meal on the PK of AN4005 will be evaluated in a separate cohort of approximately 6 patients after a safe and clinically relevant dose is identified during the dose finding part of the study.

Group II: AN4005 dose level 0 Active Control 1 Intervention

One sentinel patient will be orally dosed at 50 mg AN4005 BID. If this dose for one cycle is deemed to be tolerable upon review of safety data and PK data, the dose of AN4005 will be escalated to next level: dose level 1.

Group III: AN4005 dose level 1 Active Control 1 Intervention

Three patients will be orally dosed at 100 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).

Group IV: AN4005 dose level 2 Active Control 1 Intervention

Three patients will be orally dosed at 200 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).

Group V: AN4005 dose level 3 Active Control 1 Intervention

Three patients will be orally dosed at 400 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 4 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).

Group VI: AN4005 dose level 4 Active Control 1 Intervention

Three patients will be orally dosed at 600 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), de-escalate to lower dose or stop (\>1/6 DLT).

Who Is Running the Clinical Trial?

Adlai Nortye Biopharma Co., Ltd.

Lead Sponsor

Trials

8

Recruited

740+