APX005M + Doxorubicin for Soft Tissue Sarcoma

Recruiting at 3 trial locations

Overseen by Alexander Wei, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alexander Z. Wei, MD

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II clinical trial will evaluate the safety and efficacy of adding APX005M (a CD40 agonistic monoclonal antibody) to doxorubicin for the treatment of patients with advanced soft tissue sarcoma. The investigators believe that doxorubicin, which is currently the standard of care for most advanced sarcomas, could work better when combined with APX005M, which is a type of immunotherapy.

Research Team

Alexander Wei, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults with advanced soft tissue sarcoma that can't be removed by surgery or cured with radiation. They should have measurable disease, no prior anthracycline chemotherapy or CD40 agonist treatment, and must not have had certain heart conditions recently. Participants need to agree to use contraception and have acceptable blood counts and organ function.

Inclusion Criteria

My disease cannot be cured with surgery or radiation.

My liposarcoma has a dedifferentiated component.

Patients must have measurable disease by RECIST criteria version 1.1

Exclusion Criteria

I don't have symptoms from brain metastases and if present, they are stable and untreated with no plans for immediate treatment.

I do not have HIV or hepatitis A, B, or C.

I haven't needed antibiotics for a serious infection in the last 14 days.

Treatment Details

Interventions

• APX005M (Monoclonal Antibodies)
• Doxorubicin (Anti-tumor antibiotic)

Trial Overview The study tests the combination of APX005M (an immunotherapy drug) with doxorubicin (a standard cancer treatment) in patients with advanced sarcomas. The goal is to see if adding APX005M improves the effectiveness of doxorubicin without causing unacceptable side effects.

Participant Groups

Group I: Doxorubicin/APX005M Experimental Treatment 2 Interventions

Patients will be treated with doxorubicin and APX005M in 21 day cycles. All patients receive the same treatment (there is no "placebo" arm). After completing 8 cycles of study treatment, patients without evidence of disease progression or unacceptable toxicity may continue treatment with APX005M alone. Doxorubicin will not be continued beyond cycle 8 due to the risk for cardiac toxicity from cumulative dosing.

Who Is Running the Clinical Trial?

Alexander Z. Wei, MD

Lead Sponsor

Trials

1

Recruited

30+

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Apexigen America, Inc.

Industry Sponsor

Trials

12

Recruited

630+

Apexigen, Inc.

Industry Sponsor

Trials

12

Recruited

630+