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


Active: Yes
Cancer Type: Cervical Cancer NCT ID: NCT05032040
Trial Phases: Phase II Protocol IDs: XmAb20717-05 (primary)
NCI-2022-03108
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Xencor, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT05032040

Summary

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

Objectives

This is a Phase 2, multicenter, two-stage, open-label, parallel-group study designed to
evaluate the efficacy and safety of XmAb20717 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

- High-risk 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 DOR).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.