Trials / Completed
CompletedNCT03752398
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 198 (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 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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | XmAb®23104 | Monoclonal bispecific antibody |
| BIOLOGICAL | Yervoy® (ipilimumab) | Monoclonal antibody |
Timeline
- Start date
- 2019-05-01
- Primary completion
- 2024-02-15
- Completion
- 2024-02-15
- First posted
- 2018-11-26
- Last updated
- 2024-07-05
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03752398. Inclusion in this directory is not an endorsement.