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
Recruiting
99 years or below
All
Phase
1
6 participants needed
1 Location
Brief 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.
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
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Updated on
12 Dec 2019.
Study ID: 833962