A randomized, open-label, Phase 2/3 trial of izalontamab brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To determine the recommended Phase 3 dose (RP3D) for iza-bren to advance to Phase 3 portion of the study.

Secondary Objective:

To assess the efficacy of 2 different dose levels of izabren vs PBC in participants with advanced urothelial cancer who are IO experienced.
To determine the PK profile of iza-bren following IV administration.

Eligibility

Inclusion Criteria:

Participants must have histologically confirmed advanced urothelial carcinoma.
Participants must be eligible to receive platinum-based chemotherapy.
Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
Participants must have ≥ 1 measurable lesion per RECIST v1.1.
Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Exclusion Criteria:

Participants must not have platinum-based chemotherapy exposure within 12 months.
Participants must not have received >2 prior regimens irrespective of the setting.
Participants must not have prior ADC therapy targeting EGFR or HER3.
Participants must not have prior therapy with topoisomerase 1 inhibitor.
Participants must not have active, untreated brain metastases.

Locations

4100 John R
Detroit, MI 48201
Get Directions

Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices