A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies

Summary

Objectives

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to
evaluate the efficacy and safety of vudalimab in patients with selected advanced
gynecologic and genitourinary malignancies and to identify tumor types for further
evaluation.

In Stage 1, subjects will be enrolled into 1 of 5 tumor-specific, parallel cohorts (n =
10 each):

- Platinum-resistant high-grade serous ovarian cancer (HGSOC)

- Chemotherapy relapsed or refractory clear cell ovarian, endometrial, or peritoneal
cancer

- Immune-checkpoint-inhibitor-refractory microsatellite stable (MSS) endometrial
cancer (EC)

- Previously treated recurrent or metastatic cervical cancer

- Metastatic castration-resistant prostate cancer (mCRPC)

Within each tumor-specific cohort in Stage 1, a primary endpoint of ORR at 12 weeks,
based on Investigator review, will be used to determine cohort expansion into Stage 2.
Each Stage 1 cohort that achieves an ORR of = 20% (at least 2 out of 10 subjects with an
objective response) will enroll up to an additional 20 subjects in Stage 2. Cohorts with
an ORR of less than 20% will discontinue enrollment. However, additional factors will be
considered in determining an expansion into Stage 2 (eg, enrollment rate, complete versus
partial response, and duration of response [DOR].

In Stage 2, up to 20 additional subjects with mCRPC with or without measurable disease
will be enrolled; the primary endpoint is PSA50.