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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.
Full description
This is an open-label, multicenter, phase 1b dose-expansion study to evaluate the safety, tolerability, preliminary antitumor activity, PK, and pharmacodynamics of 2 dose levels of IK-175, administered PO in combination with nivolumab, in patients with primary PD-1-resistant metastatic or locally incurable, recurrent HNSCC for which standard therapy is no longer effective or is intolerable.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria are listed in the protocol.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Central trial contact
Marissa Timothy, MS; Jen Schroeder
Data sourced from clinicaltrials.gov
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