A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
NCT03849469 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2023-03-30
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
- BIOLOGICAL
-
XmAb®22841
Monoclonal bispecific antibody
- BIOLOGICAL
-
Pembrolizumab (Keytruda®)
FDA-approved humanized monoclonal antibody
Sponsors & Collaborators
-
ICON Clinical Research
collaborator INDUSTRY -
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Benjamin Thompson, MD, PhD · Xencor, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-29
- Primary Completion
- 2023-02-16
- Completion
- 2023-02-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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