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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have an autoimmune disease treated in the last 2 years or have had serious lung inflammation.I have moderate to severe diarrhea.My organs are functioning well.My diabetes is not well-controlled.I stopped treatment due to a severe side effect from prior immunotherapy.I am willing to switch my blood pressure medication before starting the study drug.I am on high-dose steroids or other drugs that weaken my immune system.I have received an organ or tissue transplant from another person.I am currently on blood thinners like warfarin or NOACs.I have severe pain from my cancer that isn't controlled by medication.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before starting treatment.I have active tuberculosis.I am fully active or restricted in physically strenuous activity but can do light work.I am currently taking NSAIDs.My cancer can be measured by scans and has grown in previously treated areas.I have not received a live vaccine in the last 30 days.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I am not pregnant, not breastfeeding, and meet one of the required conditions.I have been treated with drugs targeting the PKB/AKT, mTOR, or PI3K pathways.I have not had major surgery in the last 4 weeks or have fully recovered if I did.I have had 4 or fewer treatments for my advanced disease, not counting early-stage treatments.I am 18 or older and have signed the consent form for this trial.I have had cancer other than skin or early-stage cervical/breast cancer in the last 2 years.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.My cancer is advanced and cannot be removed by surgery.I cannot take pills due to a stomach condition or have issues like severe nausea.I need frequent procedures to remove fluid buildup in my body at least once a month.I had palliative radiotherapy over 2 weeks ago and have no side effects.My cancer has spread to the lining of my brain and spinal cord.I am allergic to some ingredients in atezolizumab or similar drugs.I can provide a recent or new biopsy of my tumor, not previously treated with radiation.I have had at least one treatment for my condition or there are no other treatments to extend my life.My brain metastases are stable and I haven't needed steroids for 14 days.I haven't taken antibiotics for an infection in the last 2 weeks, except for prevention.I am taking medication that affects how drugs are processed in my body and cannot switch or stop them.
Research Study Groups:
This trial has the following groups:- Group 1: DLT Observation Period I - AN2025 and Atezolizumab
- Group 2: DLT Observation Period III - AN2025, AN0025 and Atezolizumab
- Group 3: DLT Observation Period II - AN0025 and Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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