jRCT2021250056
Not yet recruiting
Not Applicable
AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER
Not provided0 sites132 target enrollmentStarted: TBD
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 132
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Age >=18 years at the time of screening.
- •Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
- •Measurable disease per RECIST v1.1 criteria.
- •ECOG performance status of 0 or
- •Adequate organ function, including hematologic, hepatic, and renal parameters.
- •Willingness to comply with study procedures and provide informed consent.
- •For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
Exclusion Criteria
- •Participants will be excluded if they meet any of the following:
- •History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- •Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- •Active autoimmune diseases requiring systemic treatment within the past 2 years
- •Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
- •Pregnant or breastfeeding individuals.
- •Inability or unwillingness to comply with study requirements.
- •Study staff or their immediate family members directly involved in the conduct of the study.
Investigators
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