A Phase 1 Open-Label Safety Pharmacokinetic and Preliminary Efficacy Study of STRO-002 An Anti-Folate Receptor alpha Antibody- Drug Conjugate (ADC) In Patients with Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers

Brief description of study

This research study is being conducted to identify the best dose of an experimental new drug called STRO-002 and to evaluate the effects of effects of STRO-002 in adults with relapsed and/or progressive epithelial ovarian and endometrial cancer including fallopian tube and primary peritoneal cancer. 

Detailed description of study

This study has two parts: Part 1 (dose escalation) and Part 2 (dose expansion). The purpose of Part 1 is to determine: What effects, good and/or bad, STRO-002 has on subjects and their disease The highest dose of STRO-002 that can be safely given to subjects using a pre-defined starting dose and rules for increasing the dose The dose of STRO-002 that has the best overall safety profile. This includes collection of side effects and measured amounts of STRO-002 in the blood at different time points, known as pharmacokinetics (PK) testing. This dose, the recommended phase 2 dose (RP2D), will be used in Part 2 of this study. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Relapsed and/or progressive epithelial ovarian, endometrial cancer. fallopian tube, primary peritoneal cancer
  • Gender: Female

Relapsed and/or progressive disease: progressed after treatment with at least 2 platinum
containing regimens or refractory to treatment with platinum containing therapy and with
no other approved treatment options.

Updated on 11 Aug 2023. Study ID: 833962

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