A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies
NCT03829501 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 222
Last updated 2025-04-02
Summary
A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.
Conditions
- Squamous Cell Carcinoma of Head and Neck
- Non-small Cell Lung Cancer
- Hepatocellular Carcinoma
- Esophageal Cancer
- Gastric Cancer
- Melanoma
- Renal Cell Carcinoma
- Pancreatic Cancer
- Cervical Cancer
- Triple Negative Breast Cancer
- Advanced Cancer
- Metastatic Cancer
Interventions
- DRUG
-
Alomfilimab
A human anti-ICOS monoclonal antibody
- DRUG
-
An anti-PD-L1 monoclonal antibody
Sponsors & Collaborators
- collaborator INDUSTRY
-
Kymab Limited
lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-28
- Primary Completion
- 2024-10-03
- Completion
- 2024-10-03
- FDA Drug
- Yes
Countries
- United States
- Hungary
- Italy
- Poland
- Taiwan
- United Kingdom
Study Locations
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