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Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

Status
Active
Cancer Type
Colon/Rectal Cancer
Melanoma
Ovarian Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05585034
Protocol IDs
XmAb808-01 (primary)
NCI-2023-00610
Study Sponsor
Xencor, Inc.

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

  1. 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
  2. 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
  3. Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
  4. Life expectancy > 3 months
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.