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

a study on Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Ocular Melanoma Skin Cancer/Melanoma Lung Cancer Non-Small Cell Lung Cancer Transitional Cell Carcinoma Kidney Cancer Renal Cell Carcinoma Prostate Cancer Ovarian Cancer Breast Cancer Triple-Negative Breast Cancer Colorectal Cancer Solid Tumor Carcinoma Head and Neck Cancer Ovarian Epithelial Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors

Details

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).

Keywords

Head and Neck Squamous Cell Carcinoma, Melanoma Excluding Uveal Melanoma, Non-small Cell Lung Cancer, Squamous or Non-squamous, Urothelial Carcinoma, Renal Cell Carcinoma, Clear Cell, Castration-resistant Prostate Cancer, Ovarian Cancer, Epithelial, TNBC - Triple-Negative Breast Cancer, Colorectal Cancer, Carcinoma, Melanoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Epithelial Carcinoma, Pembrolizumab, XmAb®808, Keytruda® (pembrolizumab)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • Huntsman Cancer Institute, University of Utah accepting new patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Xencor, Inc.
ID
NCT05585034
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated