Oral AHR Antagonist in Combination With Nivolumab in Patients With Resistant or Recurrent Head and Neck Cancer

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ikena Oncology
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

Key Inclusion Criteria:

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Subject has a histologically confirmed metastatic or locally incurable, recurrent HNSCC that has progressed within 12 weeks of initiation of PD-1 inhibitor agent, whether it was administered alone or in combination with chemotherapy.

• Tumors must express PD-L1 with a minimum CPS ≥ 1.

• Subjects can be enrolled regardless of their tumor's expression of human papillomavirus (HPV).

• Subjects are required to have received prior treatment with a platinum-based chemotherapy in the recurrent or metastatic disease setting, unless medically contraindicated.

• Subject has at least 1 measurable lesion per RECIST v1.1.

Key Exclusion Criteria:

• Subject has untreated or symptomatic central nervous system (CNS) tumors or brain metastases.

• Subject must have recovered to ≤ Grade 1 from clinically significant AEs related to prior therapy (eg, myelosuppression or renal or hepatic dysfunction.)

• Subject has received prior treatment with an AHR inhibitor.

• Subject has a medical condition that limits oral administration or impairment of gastrointestinal function that is expected to significantly reduce the absorption of IK-175.

• Uncontrolled or life-threatening symptomatic concomitant disease.

• Clinically significant cardiovascular disease as defined in the protocol.

• Subject is on a medication that is a sensitive substrate of CYP2C8, 2C9, 2C19, or 3A4 that cannot be substituted.

• Females who are pregnant or breastfeeding.

Other inclusion/exclusion criteria are listed in the protocol.