Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT05472506
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05472506
Study Brief:
Protocol Section:
NCT05472506