AN0025 + Pembrolizumab for Advanced Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Adlai Nortye Biopharma Co., Ltd.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

Research Team

Robert Atkinson, Ph.D.

Principal Investigator

Adlai Nortye US Inc

Eligibility Criteria

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.

Inclusion Criteria

My cancer has worsened despite treatment with specific immune therapy.

I am a man and agree to use birth control during and for 4 months after treatment.

My cancer can be measured by scans.

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Exclusion Criteria

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

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

My cancer has spread to my brain or its coverings.

See 18 more

Treatment Details

Interventions

AN0025 (Other)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Phase 1b: Urothelial carcinoma of the bladderExperimental Treatment2 Interventions