Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
Colon/Rectal Cancer
Melanoma
Ovarian Cancer
18 Years and older, Male and Female
XmAb808-01 (primary)
NCI-2023-00610
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.
Objectives
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
- 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
Treatment Sites in Georgia
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