Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
NCT06322108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-05-08
Summary
The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment.
Conditions
Interventions
- DRUG
-
Botensilimab + Balstilimab
Botensilimab is a fragment crystallizable (Fc)-engineered human immunoglobulin G1 (IgG1) monoclonal antibody that targets cytotoxic T lymphocyte-associated protein 4 (CTLA-4). Balstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1).
Sponsors & Collaborators
-
Agenus Inc.
collaborator INDUSTRY -
Immune Oncology Research Institute
lead OTHER
Principal Investigators
-
Gevorg Tamamyan, MD, PhD, DSc · Immune Oncology Research Institute
-
Samvel Bardakhchyan, MD, PhD · Immune Oncology Research Institute
-
Samvel Bardakhchyan, MD, PhD · Immune Oncology Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-13
- Primary Completion
- 2030-04-30
- Completion
- 2030-04-30
- FDA Drug
- Yes
Countries
- Armenia
Study Locations
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