NCT05032040

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

A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and Metastatic Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to evaluate the efficacy and safety of vudalimab (XmAb20717) in patients with selected advanced gynecologic and genitourinary malignancies.

Detailed description

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.

Conditions

• Ovarian Cancer
• Clear Cell Carcinoma
• Endometrial Cancer
• Cervical Carcinoma
• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
BIOLOGICAL	vudalimab	Monoclonal bispecific antibody

Timeline

• Start date: 2022-07-21
• Primary completion: 2025-10-15
• Completion: 2025-12-30
• First posted: 2021-09-02
• Last updated: 2025-02-07

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study