NCT03849469

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

Conditions

• Melanoma
• Cervical Carcinoma
• Pancreatic Carcinoma
• Triple Negative Breast Cancer
• Hepatocellular Carcinoma
• Urothelial Carcinoma
• Squamous Cell Carcinoma of the Head and Neck
• Nasopharyngeal Carcinoma
• Renal Cell Carcinoma
• Non-small Cell Lung Carcinoma
• Small Cell Lung Carcinoma
• Gastric or Gastroesophageal Junction Adenocarcinoma
• Advanced or Metastatic Solid Tumors
• Prostate Carcinoma
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma
• Intrahepatic Cholangiocarcinoma
• Squamous Cell Anal Cancer
• Squamous Cell Penile Carcinoma
• Squamous Cell Vulvar Carcinoma
• Colorectal Carcinoma
• Endometrial Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	XmAb®22841	Monoclonal bispecific antibody
BIOLOGICAL	Pembrolizumab (Keytruda®)	FDA-approved humanized monoclonal antibody

Timeline

• Start date: 2019-05-29
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2019-02-21
• Last updated: 2023-03-30

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study