AN0025 + Pembrolizumab for Advanced Cancer

Recruiting at 5 trial locations

Overseen ByRobert Atkinson, MSCR, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adlai Nortye Biopharma Co., Ltd.

Must be taking: Anti-PD-1/PD-L1 mAb

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Active infection, Autoimmune, others

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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Robert Atkinson, Ph.D.

Principal Investigator

Adlai Nortye US Inc

Are You a Good Fit for This Trial?

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.

See 10 more

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Limiting Toxicity Observation

Observation phase to evaluate dose-limiting toxicities of AN0025 in combination with pembrolizumab

3 weeks

1 visit every 3 weeks (in-person)

Treatment

Participants receive AN0025 and Pembrolizumab until disease progression, unacceptable toxicity, or withdrawal, for up to 35 cycles

Approximately 2 years

1 visit every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

AN0025
Pembrolizumab

Trial Overview 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.

How Is the Trial Designed?

6Treatment groups

Experimental Treatment

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