A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
NCT03752398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2024-07-05
Summary
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.
Conditions
- Melanoma (Excluding Uveal Melanoma)
- Cervical Carcinoma
- Pancreatic Carcinoma
- Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
- Hepatocellular Carcinoma
- Urothelial Carcinoma
- Squamous Cell Carcinoma of the Head and Neck
- Nasopharyngeal Carcinoma
- Renal Cell Carcinoma
- Colorectal Carcinoma
- Endometrial Carcinoma
- Non-small Cell Lung Carcinoma
- Small Cell Lung Cancer
- Gastric or Gastroesophageal Junction Adenocarcinoma
- Advanced Solid Tumors
- Undifferentiated Pleomorphic Sarcoma
Interventions
- BIOLOGICAL
-
XmAb®23104
Monoclonal bispecific antibody
- BIOLOGICAL
-
Yervoy® (ipilimumab)
Monoclonal antibody
Sponsors & Collaborators
- collaborator INDUSTRY
-
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Chet Bohac, MD, MSc · Xencor, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2024-02-15
- Completion
- 2024-02-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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