APX005M + Pembrolizumab for Melanoma

Overseen By Adi Diab, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Immune checkpoint inhibitors

Disqualifiers: Autoimmune disease, Heart failure, others

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

Compensation: Varies

Number of Visits: 9

32 Participants Needed

Trial Summary

What is the purpose of this trial?

You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma. The safety of this drug combination will also be studied. This is an investigational study. APX005M is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. The combination of these drugs to treat metastatic melanoma is investigational. The study doctor can explain how the study drug is designed to work. Up to 41 participants will be treated in this study. All will take part at MD Anderson.

Research Team

Adi Diab

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This study is for adults with metastatic melanoma that has spread and hasn't been treated with pembrolizumab or similar drugs before. Participants need to have good liver function, not be pregnant, agree to use contraception, and have a performance status indicating they are relatively active. They should not have had recent cancer treatments or surgeries, no history of certain heart conditions or severe infections.

Inclusion Criteria

I agree to use effective birth control during and for 4 months after the study.

I have at least two melanoma lesions that can be injected, each larger than 10 mm.

I am fully active or can carry out light work.

Exclusion Criteria

I have not had a blood clot in an artery in the last 3 months.

I've only had certain skin cancers, in-situ cervical cancer, non-anaplastic thyroid cancer, or have been cancer-free for 2 years.

You have a condition that weakens your immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Dose Escalation

Participants receive APX005M at escalating doses to determine the maximum tolerated dose, in combination with pembrolizumab

12 weeks

Weekly visits for drug administration and monitoring

Dose Expansion

Participants receive APX005M at the maximum tolerated dose determined in the Dose Escalation phase, in combination with pembrolizumab

12 weeks

Weekly visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Scans every 8-12 weeks, phone calls every 3 months

Treatment Details

Interventions

• APX005M
• Pembrolizumab

Trial Overview The trial is testing the highest dose of APX005M that can be safely given with FDA-approved pembrolizumab in patients with metastatic melanoma. The aim is to see if this drug combination helps control the disease better than current treatments. All participants will receive both drugs at MD Anderson Cancer Center.

Participant Groups

Group I: APX005M + Pembrolizumab Experimental Treatment 2 Interventions

Dose Escalation Phase: Starting dose level of APX005M is 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses. Tumor site chosen based on volume to be injected. All participants receive Pembrolizumab at 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M. Dose Expansion Phase: Starting dose level of APX005M is maximum tolerated dose from Dose Escalation Phase. Participants receive same dosage of Pembrolizumab as in Dose Escalation Phase.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Pyxis Oncology

Collaborator

Trials

1

Recruited

30+

Apexigen, Inc.

Industry Sponsor

Trials

12

Recruited

630+

Apexigen America, Inc.

Industry Sponsor

Trials

12

Recruited

630+