Batiraxcept + Paclitaxel for Uterine Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid G Mutch, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine safety and tolerability of AVB-500 when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer.

Research Team

David G Mutch, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for women or transgender men with a uterus, aged 18+, who have recurrent high-grade uterine cancer that's not treatable by standard methods. They must be relatively healthy, with specific blood counts and organ functions within normal ranges, and no severe heart disease or active infections. Participants need measurable cancer lesions and can't be pregnant; they must use contraception if possible.

Inclusion Criteria

Measurable disease by RECIST 1.1

- Absolute neutrophil count ≥ 1.5 K/cumm

Ability to understand and willingness to sign an IRB approved written informed consent document

See 15 more

Exclusion Criteria

I have cancer that has spread to my brain.

I have previously been treated with AVB-500.

I have a wound, ulcer, or bone fracture that hasn’t healed.

See 12 more

Treatment Details

Interventions

AVB-500 (Batiraxcept) (Monoclonal Antibodies)
Paclitaxel (Anti-microtubule agent)

Trial OverviewThe study tests the safety of AVB-500 (Batiraxcept) combined with Paclitaxel in patients with recurrent high-grade uterine cancer. It aims to understand how well patients tolerate this combination therapy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Paclitaxel + AVB-500Experimental Treatment2 Interventions

Patients will receive up to 9 21-day cycles of paclitaxel + AVB-500. Patients will receive AVB-500 via intravenous (IV) infusion at the assigned dose level on days 1, 8, and 15 of each cycle. Patients will receive IV paclitaxel at a dose of 175 mg/m\^2 on day 1 of each cycle. After 3 cycles, patients will be assessed for disease response. Patients who have progression will not continue on treatment. Patients who have a partial response or stable disease will continue on treatment for another 3 cycles of paclitaxel + AVB-500 at the assigned dose. Patients will be assessed for response again at the end of 6 cycles and may continue on treatment if they have partial response (PR) or stable disease (SD). Up to 9 cycles of treatment with paclitaxel + AVB-500 may be given. At the end of the 9 cycles, patients with a SD or PR can continue on maintenance AVB-500 until progression. Patients with complete response will continue single agent AVB-500 as maintenance therapy until progression.