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

  • STATUS
    Recruiting
  • participants needed
    6
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Updated on 19 February 2024

Summary

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. Levels (if any) of antibodies in the blood which may arise in response to study drug known as anti-drug antibodies (ADA) During Part 2, subjects will be dosed at the applicable RP2D selected from Part 1 of the study. The purpose of Part 2 is to determine: What effects, good and/or bad, STRO-002 has on subjects including ADA as defined above How their cancer responds to treatment with STRO-002 The amount of STRO-002 in the blood at different times (PK) Key Eligibility

Details
Condition Medical Research
Age 99years or below
Clinical Study IdentifierTBD
Last Modified on19 February 2024

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