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Double Antibody-Drug Conjugate Trial Enrolling in Metastatic Bladder Cancer

By: Vanessa A. Carter, BS
Posted: Thursday, March 24, 2022

During the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, Bradley Alexander McGregor, MD, of Dana-Farber Cancer Institute, Boston, and colleagues presented details on their upcoming phase I study on sacituzumab govitecan-hziy plus enfortumab vedotin-ejfv in patients with metastatic urothelial carcinoma (Abstract TPS588). These investigators hypothesize that since these antibody-drug conjugates have nonoverlapping toxicities, when taken together, they may be likely to have manageable safety with additive antitumor activity.

This single-center, open-label trial plans to enroll up to 24 patients with metastatic urothelial carcinoma who experienced disease progression on PD-L1 inhibitors or platinum-based chemotherapy and will use a Bayesian Optimal Interval design. Participants will be administered intravenous sacituzumab govitecan plus enfortumab vedotin every 3 weeks on days 1 and 8 until disease progression or unacceptable toxicity.

Laboratory evaluation will be performed during days 1 and 8 of each study for antidrug antibody and pharmacokinetic studies; imaging will be performed at baseline as well as every 6 weeks for four cycles and every 9 weeks thereafter. The combination treatment will be given for up to four dose levels with a sacituzumab govitecan starting dose of 8 mg/kg and an initial enfortumab vedotin dose of 1.0 mg/kg; doses will range from 6 to 10 mg/kg and 1.0 to 1.25 mg/kg, respectively.

Approximately 3 to 18 individuals are to be enrolled in current dose levels according to dose-limiting toxicities, which will be assessed during cycle 1 and up to 4 weeks after the first dose. Dose-limiting toxicities will include the following: thrombocytopenic bleeding, grade 3 neuropathy, neutropenic fever, and any other nonhematologic toxicity lasting longer than 1 week. Of note, the first patient in each cohort is required to complete one full cycle before additional patients can be enrolled.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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