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733 A phase 2 study of vudalimab (XmAb®20717), an anti-PD-1/CTLA-4 bispecific antibody, in patients with selected gynecological malignancies and high-risk metastatic castration-resistant prostate-cancer
  1. June Hou1,
  2. Oscar Goodman2,
  3. David Berz3,
  4. Li Yao4 and
  5. Nital Soni4
  1. 1Columbia University Irving Medical Center, New York, NY, Untied States
  2. 2Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA
  3. 3Valkyrie Clinical Trials, Los Angeles, CA, USA
  4. 4Xencor, Inc., Monrovia, CA, USA


Background Vudalimab (XmAb20717) is a humanized bispecific monoclonal antibody that simultaneously targets PD-1 and CTLA-4 and binds preferentially to PD-1/CTLA-4 dual-positive cells. In a Phase 1 study, vudalimab was generally well-tolerated and associated with complete and partial responses in various solid tumor types, including ovarian cancer and metastatic castration-resistant prostate cancer (mCRPC).1 These tumor types typically are not responsive to single-agent immune checkpoint inhibitor (ICI) therapy but have shown better outcomes in studies in which anti-PD-1 and CTLA-4 therapies have been combined. This Phase 2 study is designed to evaluate the safety and antitumor activity of vudalimab in selected gynecological oncologic indications and high-risk mCRPC.

Methods This is a multicenter, two-stage, open-label study being conducted in the United States. Patients with histologically confirmed platinum-resistant high-grade serous ovarian cancer; chemotherapy relapsed or refractory clear cell ovarian, endometrial, or peritoneal cancer; ICI-refractory microsatellite stable (MSS) endometrial cancer (EC); previously treated recurrent or metastatic cervical cancer; or high-risk mCRPC will be enrolled into parallel cohorts. Patients must have measurable disease by response evaluation criteria in solid tumors (RECIST) 1.1. Prior treatment with anti-PD-1 and PDL-1/PDL-2 therapy is excluded, except for patients with MSS EC and cervical cancer; prior anti-CTLA-4 treatment is excluded for all patients. Vudalimab will be administered intravenously every 3 weeks at a fixed dose of 1000 mg (1200 mg for patients ≥ 80 kg). Antitumor effects will be evaluated using RECIST 1.1; additionally, disease assessment via bone scans and PSA will be performed in patients with mCRPC. Safety and tolerability will be assessed based on treatment-emergent adverse events. Pharmacodynamic effects in peripheral blood and tumor, and potential biomarkers associated with clinical response will be explored. In Stage 1 (n = 10/cohort), a primary endpoint of objective response rate (ORR) ≥ 20% at 12 weeks (based on investigator review) will determine which cohorts advance into Stage 2 (n = 20/cohort), where primary and secondary endpoints of ORR (based on independent central review) and duration of response, respectively, will be determined for the combined number of patients enrolled into Stages 1 and 2 (n = 30). Enrollment has been initiated.

Trial Registration NCT05032040


  1. [1] Shum E, Reilley M, Najjar Y, et al. 523 Preliminary clinical experience with XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors. Journal for ImmunoTherapy of Cancer. 2021;9: doi: 10.1136/jitc-2021-SITC2021.523

Ethics Approval The study was approved by each institution’s IRB.

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