Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Neoplasms

Disease Attributes

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

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.

Batiraxcept

David G Mutch, M.D.

Katherine Fuh, M.D., Ph.D.

Andrea R Hagemann, M.D.

Ian Hagemann, M.D.

Lindsay Kuroki, M.D.

L. Stewart Massad, M.D.

Carolyn McCourt, M.D.

Dineo Khabele, M.D.

Matthew A Powell, M.D.

Premal Thaker, M.D.

Maggie Mullen, M.D.

Esther Lu, Ph.D.

Carolyn Muller, M.D.

Kathleen Moore, M.D.

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.

AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Phase I/IB of AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

-Defined as the proportion of subjects who have a partial or complete response to therapy

-Defined as the time from start of treatment to the first radiologically documented disease progression, or death, whichever comes first. The alive patients without radiologically documented disease progression are censored at the last follow-up.

-Defined as the time from start of treatment to death. The alive patients are censored at the last follow-up.

National Cancer Institute (NCI)

Aravive, Inc.

Washington University School of Medicine

Spots Global Cancer Trial Database for recurrent high grade uterine cancer