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Other

Combination Therapy for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Adlai Nortye Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Have received no more than 4 prior lines of systemic therapy for advanced disease. Prior therapy in an adjuvant or neoadjuvant setting is not considered as a prior line of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing the safety and preliminary efficacy of two drugs, AN2025 and AN0025, when used in combination with the drug atezolizumab to treat patients with locally advanced or metastatic tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs which could lead to symptoms like fatigue, digestive issues or skin problems; allergic reactions specific to drug components; increased risk of infections due to lowered immunity; possible liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had 4 or fewer treatments for my advanced disease, not counting early-stage treatments.
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I am 18 or older and have signed the consent form for this trial.
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My cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure - Dose Limiting Toxicities (DLTs)
Measure - Number of participants with adverse events and serious adverse events
Secondary outcome measures
Duration of Response (DOR)
Efficacy by Phosphatidylinositol-4,5-bisphosphate 3 Kinase Catalytic Subunit Alpha (PIK3CA) mutation in DLT Observations I and III
Overall Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: DLT Observation Period III - AN2025, AN0025 and AtezolizumabExperimental Treatment3 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 AtezolizumabExperimental Treatment2 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 AtezolizumabExperimental Treatment2 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.

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Who is running the clinical trial?

Adlai Nortye Biopharma Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
677 Total Patients Enrolled
Robert Atkinson, PhD, MSCRStudy DirectorAdlai Nortye US Inc

Media Library

AN0025 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04975958 — Phase 1
Solid Tumors Research Study Groups: DLT Observation Period I - AN2025 and Atezolizumab, DLT Observation Period III - AN2025, AN0025 and Atezolizumab, DLT Observation Period II - AN0025 and Atezolizumab
Solid Tumors Clinical Trial 2023: AN0025 Highlights & Side Effects. Trial Name: NCT04975958 — Phase 1
AN0025 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975958 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~18 spots leftby Mar 2025