Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ikena Oncology
Study ID
NCT05472506
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2023
Status verified
Mar 2024
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    600 mg qd PO IK-175 + nivolumab
  • Experimental: Cohort 2
    450 mg q12h PO IK-175 + nivolumab

Primary Outcome Measure

Frequency and severity of treatment emergent adverse events (TEAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability] [ Time Frame: Treatment Period (Approximately 18 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-
Washington UniversitySt LouisMissouri63130-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Chicago, IL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Chicago Medical Center· Chicago, ILWashington University· St Louis, MOUPMC Hillman Cancer Center· Pittsburgh, PASeattle Cancer Care Alliance· Seattle, WA

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