Combination Therapy for Solid Tumors

Recruiting at 4 trial locations

Overseen By Robert Atkinson, PhD, MSCR

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adlai Nortye Biopharma Co., Ltd.

Must not be taking: NSAIDs, ACE inhibitors, ARBs, others

Disqualifiers: Active infection, CNS metastases, others

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

Compensation: Varies

Number of Visits: 3

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two new drugs, AN2025 and AN0025, alone and with an existing cancer drug, Atezolizumab, in patients with advanced or spreading tumors. The goal is to see if these new drugs can help fight cancer better, either by themselves or by enhancing the effects of Atezolizumab.

Research Team

Robert Atkinson, PhD, MSCR

Principal Investigator

Adlai Nortye US Inc

Eligibility Criteria

Adults (18+) with advanced solid tumors who have signed consent, can follow the trial protocol, and have a life expectancy of at least 3 months. They must have measurable disease, adequate heart function, and acceptable organ function levels. Women must not be pregnant or breastfeeding and agree to contraception; men also need to use contraception. Participants should have had prior systemic therapy unless no other survival-prolonging options exist but no more than four lines of treatment for advanced disease.

Inclusion Criteria

Life expectancy ≥3 months

My organs are functioning well.

Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan

Exclusion Criteria

Are currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment

I have severe nerve pain, lung or colon inflammation, high blood sugar, or uncontrolled thyroid issues from past treatments.

I have not had an infection needing treatment in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DLT Observation Period I

Patients are treated with AN2025 and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks

1 visit every 3 weeks

DLT Observation Period II

Patients are treated with AN0025 and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks

1 visit every 3 weeks

DLT Observation Period III

Patients are treated with AN2025, AN0025, and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• AN0025
• AN2025
• Atezolizumab

Trial Overview The study is testing AN2025 and AN0025 in combination with Atezolizumab against advanced/metastatic tumors. It's an early-phase trial assessing safety, how well the body handles these drugs (pharmacokinetics), tolerability, and initial effectiveness. Patients will receive either double or triple combinations of these treatments.

Participant Groups

Group I: DLT Observation Period III - AN2025, AN0025 and Atezolizumab Experimental Treatment 3 Interventions

The DLT Observation III will be started after safety data review by the investigators and the sponsor of the double combination treatments in Observations I and II. Patients enrolled in Observation III will start with the recommended dose of AN0025 from Observation II, 1200 mg Atezolizumab, and AN2025 will start from 50 mg QD. Patients will be treated with all three study drugs until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The dose of Atezolizumab will be the same (i.e., 1200 mg Q3W) regardless of dose levels of AN2025 and cohorts. Atezolizumab is administered intravenously over 60 minutes every three weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. The dose of AN0025 as determined in Observation II will remain constant for each dose level of AN2025 and each cohort, unless the investigators and the sponsor determine that the toxicity comes from the AN0025 + Atezolizumab combination.

Group II: DLT Observation Period II - AN0025 and Atezolizumab Experimental Treatment 2 Interventions

During the DLT Observation II, patients will be treated with AN0025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN0025 is 250 mg. If tolerated, then a subsequent cohort will escalate to 500 mg. If 250 mg AN0025 is not tolerated, de-escalate to 125 mg. The dose of Atezolizumab will remain constant at 1200 mg Q3W for each dose level of AN0025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Group III: DLT Observation Period I - AN2025 and Atezolizumab Experimental Treatment 2 Interventions

During the DLT Observation I, patients will be treated with AN2025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN2025 is 50 mg. If tolerated, then a subsequent cohort will escalate to 100 mg. A dose de-escalation cohort to 80 mg may occur if the 100 mg is not well tolerated. The dose of Atezolizumab will remain constant at 1200 mg every 3 weeks (Q3W) for each dose level of AN2025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Who Is Running the Clinical Trial?

Adlai Nortye Biopharma Co., Ltd.

Lead Sponsor

Trials

8

Recruited

740+