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

Inclusion Criteria

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