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AN0025 + Pembrolizumab for Advanced Cancer

Phase 1

Waitlist Available

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

Have progressed on treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies

Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist

Must not have

Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

Received prior radiotherapy within 2 weeks of start of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination drug to treat advanced tumors. The goal is to find the best dose of the new drug while monitoring side effects. The trial will last for two years.

Who is the study for?

This trial is for adults with certain advanced solid tumors who've had no more than 3 prior systemic therapies and have progressed after anti-PD-1/PD-L1 treatment. They must have good organ function, measurable disease, an ECOG status of 0 or 1, a life expectancy over 3 months, and agree to contraception use. Exclusions include recent other cancer treatments, severe allergies to study drugs, active pneumonitis or autoimmune diseases requiring treatment in the last two years.

What is being tested?

The trial tests AN0025 combined with pembrolizumab on patients with advanced/metastatic tumors. It includes initial observation for dose-limiting toxicity followed by expansion phase treatment up to approximately two years or until disease progression or unacceptable side effects occur.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs (like lungs), infusion-related reactions, fatigue, digestive issues possibly leading to diarrhea or colitis-like symptoms, skin rashes and potential increase in risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened despite treatment with specific immune therapy.

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My cancer can be measured by scans.

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My cancer is advanced and cannot be removed by surgery.

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I have had 3 or fewer treatments for my advanced illness.

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I have given a sample of my tumor that was not treated with radiation.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken steroids or immunosuppressants in the last 7 days.

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I had radiotherapy less than 2 weeks before starting the study treatment.

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My cancer has spread to my brain or its coverings.

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I am currently on medication for an infection.

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I have had pneumonitis treated with steroids or have it now.

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I stopped treatment because of a severe reaction to immunotherapy.

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I have not had major surgery in the last 4 weeks.

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I have inflammatory bowel disease.

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I haven't had cancer treatment or experimental drugs in the last 4 weeks.

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I cannot take pills by mouth due to a digestive issue.

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I have received an organ or tissue transplant from another person.

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I have HIV or a history of Hepatitis B or C.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.