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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma Head and Neck Cancer Head Cancer Neck Cancer Head Cancer Neck Neck Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized 1:1 to Cohort 1 or Cohort 2

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

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Cohort 1

600 mg qd PO IK-175 + nivolumab

Group Type EXPERIMENTAL

IK-175 + nivolumab

Intervention Type DRUG

IK-175 + nivolumab

Cohort 2

450 mg q12h PO IK-175 + nivolumab

Group Type EXPERIMENTAL

IK-175 + nivolumab

Intervention Type DRUG

IK-175 + nivolumab

Interventions

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IK-175 + nivolumab

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No