Ovarian Cancer Clinical Trial
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.
Full Description
This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).
Eligibility Criteria
Key Inclusion Criteria:
Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies
Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy
Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
Life expectancy > 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key Exclusion Criteria:
Subjects currently receiving other anticancer therapies
Any prior treatment with an investigational agent targeting CD28
History of a life-threatening adverse event related to prior immunotherapy
Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
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There are 12 Locations for this study
Los Angeles California, 90095, United States
Denver Colorado, 80218, United States
Sarasota Florida, 34232, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
New York New York, 10032, United States
Cincinnati Ohio, 45219, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Milwaukee Wisconsin, 53226, United States
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