Study on Luveltamab Tazevibulin vs. Chemotherapy for Women with Ovarian Cancer Expressing FOLR1

Sponsor: Sutro Biopharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05870748

Provider View

This clinical trial is testing a new drug, Luveltamab Tazevibulin, against standard chemotherapy in women with ovarian cancer that expresses the FOLR1 protein. The study aims to determine which treatment is more effective and safer.

Patient Parameters

Program Overview

This study is exploring the effectiveness and safety of a new drug, Luveltamab Tazevibulin, compared to standard chemotherapy in women with ovarian cancer, including cancers of the fallopian tube or primary peritoneal area, that express the FOLR1 protein. The trial is divided into two parts: the first part will test different doses of Luveltamab Tazevibulin to find the best one, and the second part will compare this dose to standard chemotherapy. The drug is given through an IV infusion every three weeks.

Description

This international study is being conducted in multiple centers and is open to women with relapsed ovarian cancer that is resistant to platinum-based treatments and expresses the FOLR1 protein. The study is divided into two parts. In the first part, participants will be randomly assigned to receive one of two different doses of Luveltamab Tazevibulin to determine the best dose. In the second part, the selected dose will be compared to standard chemotherapy to see which is more effective and safer. Luveltamab Tazevibulin is administered through an IV infusion over one hour every three weeks.

Eligibility Criteria

Inclusion Criteria

  • Women with high-grade serous epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Cancer must express the FOLR1 protein, confirmed by lab tests.
  • Cancer has returned and is resistant to platinum-based treatments, with 1 to 3 previous treatment regimens.
  • Must have received prior treatment with bevacizumab if it is standard care, unless there is a medical reason not to.
  • At least one measurable tumor according to standard criteria.
  • Must have adequate organ function.

Exclusion Criteria

  • Low-grade ovarian cancer or other specific types like clear cell, mucinous, or endometrioid.
  • Previous treatment with drugs targeting FOLR1 or those containing a tubulin inhibitor.
  • Cancer that did not respond to initial platinum-based treatment.
  • History of severe allergic reactions to antibody treatments.
  • Significant eye disorders, severe lung diseases like COPD or asthma, heart or blood vessel diseases, or other uncontrolled medical conditions.
  • Previous organ transplant.
  • Signs of cancer in the brain or spinal cord.
  • Currently participating in another treatment trial.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.