Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer
NCT05472506 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-03-15
Summary
This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Head and Neck Cancer
- Head Cancer
- Neck Cancer
- Head Cancer Neck
- Neck Carcinoma
Interventions
- DRUG
-
IK-175 + nivolumab
IK-175 + nivolumab
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ikena Oncology
lead INDUSTRY
Principal Investigators
-
Katherine Kim, MD · Ikena Oncology
-
Karim Malek, MD · Ikena Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2023-04-30
- Completion
- 2023-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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