Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: Approximately 2 years

AN0025 + Pembrolizumab for Advanced Cancer

Not currently recruiting at 6 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 trial tests the safety and early effectiveness of a new treatment combination for advanced cancers. It involves AN0025, taken as a pill, and Pembrolizumab, an immunotherapy drug administered through an IV, to evaluate their combined effect on difficult-to-treat tumors, such as certain lung, bladder, and breast cancers. The trial seeks participants with these cancers who have not responded to other treatments. Those dealing with these advanced cancers and who have had little success with other therapies might consider this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any prior systemic anti-cancer therapy within 4 weeks before starting the trial treatment, and you should not be on chronic systemic steroid therapy exceeding 10 mg daily of prednisone equivalent.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pembrolizumab is generally safe for patients with various types of cancer. Its approval for certain cancers indicates well-established safety. In contrast, AN0025 remains under study, and its safety profile is less understood. This trial is in the early stages, focusing primarily on safety assessment.

While pembrolizumab's safety is well-documented, AN0025's effects are still being explored. Participants in early studies like this one might experience side effects, but researchers are still determining their nature and frequency. Prospective participants should discuss potential risks and benefits with a healthcare professional.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Unlike the standard of care, which often involves chemotherapy or targeted therapies, AN0025 combined with Pembrolizumab is unique because it targets the cancer's immune evasion mechanisms. Most treatments for these cancers focus on directly attacking cancer cells, but AN0025 works by inhibiting the prostaglandin E2 (PGE2) pathway, potentially enhancing the immune system's ability to fight the tumor. Pembrolizumab, an immune checkpoint inhibitor, further boosts the immune response by blocking the PD-1 pathway. Researchers are excited about this combination because it offers a novel approach to tackling advanced cancers, potentially leading to more effective and durable responses.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that pembrolizumab, a key component of the treatment combination in this trial, effectively treats various cancer types. One study found that patients with certain cancers lived more than twice as long with pembrolizumab compared to chemotherapy, suggesting it can extend life expectancy. This trial examines AN0025 for its potential to enhance pembrolizumab's ability to help the immune system fight cancer. While detailed information on AN0025 is still being gathered, its combination with pembrolizumab offers a promising new approach to treating advanced cancers.¹ ² ⁶ ⁷ ⁸

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