Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Description

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

Conditions

Metastatic Urothelial Cancer

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Study Overview

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Study Details

Study overview

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Condition
Metastatic Urothelial Cancer
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Fullerton

Virginia K. Crosson Cancer Center at St. Jude Medical Center, Fullerton, California, United States, 92835

Orange

University of California - Irvine Medical Center, Orange, California, United States, 92868

San Francisco

University of California, San Francisco (UCSF), San Francisco, California, United States, 94158

Jacksonville

Cancer Specialists of North Florida, Jacksonville, Florida, United States, 32266

Miami Beach

Mount Sinai Medical Center of Florida, Inc., Miami Beach, Florida, United States, 33140

Miami

University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Miami

AP Medical Research, Miami, Florida, United States, 33165

Springfield

Southern Illinois University (SIU) - Simmons Cancer Institute, Springfield, Illinois, United States, 62702

Des Moines

Mission Cancer + Blood, Des Moines, Iowa, United States, 50309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Life expectancy ≥ 12 weeks.
  • * Measurable disease as defined by RECIST v1.1.
  • * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra.
  • * Archival or fresh tumor tissue comprising muscle-invasive UC or locally advanced or metastatic UC should be available for submission to central laboratory.
  • * Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at Screening and negative urine or serum test within 72 hours prior to the first dose).
  • * Cohort 1: Previously Untreated: Eligible to receive platinum-based chemotherapy (either cisplatin- or carboplatin-based chemotherapy based on Investigator decision.
  • * Cohort 1: Participants must not have received prior systemic therapy for locally advanced or metastatic UC with the following exceptions:
  • 1. Prior local intravesical chemotherapy, local surgery when full resection is not achieved, local immunotherapy, and radiotherapy are permitted if completed at least 4 weeks prior to the initiation of study treatment and all acute toxicities have resolved.
  • 2. Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based therapy with recurrence \>12 months from completion of therapy.
  • 3. Prior neoadjuvant/adjuvant immune checkpoint inhibitor therapy with recurrence \>12 months from completion of therapy.
  • * Cohort 2: Previously Treated: Participants must have received ≥ 1 prior systemic treatment for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
  • * Cohort 2: Progression or recurrence of UC during or following receipt of most recent therapy.
  • * Active keratitis or corneal ulcerations.
  • * Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
  • * Any condition requiring current treatment with high dose corticosteroids (\> 10 mg daily prednisone or equivalent).
  • * Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
  • * Has not adequately recovered from recent major surgery (excluding placement of vascular access).
  • * Receipt of live or attenuated vaccine within 30 days of first dose.
  • * Cohort 1: Previously Untreated: Prior treatment with a checkpoint inhibitor (CPI) for any other malignancy within the last 12 months.
  • * Cohort 2: Previously Treated: Received more than 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
  • * Cohort 2: Prior treatment with enfortumab vedotin or any other MMAE-based therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BicycleTx Limited,

Study Record Dates

2030-12