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Clinical Trials List

Protocol NumberBT8009-230

NCT Number(ClinicalTrials.gov Identfier)NCT06225596

Active

2024-06-01 - 2030-12-31

Phase II/III

Recruiting6

ICD-10C68.0

Malignant neoplasm of urethra

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9189.3

Malignant neoplasm of urethra

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)

Trial Applicant

MEDPACE TAIWAN LIMITED
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/17

Investigators and Locations

Principal Investigator 黃冠華無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Jung Su 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Urothelial Cancer

Objectives

The aim of this trial was to investigate the efficacy and safety of BT8009 as a monotherapy and in combination with pembrolizumab compared to chemotherapy in participants with locally advanced or metastatic urothelial carcinoma.

Test Drug

Injectable frozen powder

Active Ingredient

BT8009

Dosage Form

048

Dosage

12 mg/vial

Endpoints

Group 1: Treatment-naïve

• Efficacy of BT8009 combined with pembrolizumab, measured as progression-free survival (PFS) by blinded independent central review (BICR) according to RECIST v1.1.

Group 2: Treatment-naïve

• Efficacy of BT8009 monotherapy combined with pembrolizumab, measured as objective response rate by blinded independent central review according to RECIST v1.1.

Inclution Criteria

Key Inclusion 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 primary 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:

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.
Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based therapy with recurrence >12 months from completion of therapy.
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.

Exclusion Criteria

Key Exclusion Criteria:

Active keratitis or corneal ulcerations.
Requirement, while receiving study medications, 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

The Estimated Number of Participants

Taiwan

33 participants
Global

956 participants