Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 5:46 PM
Study NCT ID:
NCT05472506
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2022-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 1:1 to Cohort 1 or Cohort 2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of treatment emergent adverse events (TEAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]', 'timeFrame': 'Treatment Period (Approximately 18 months)', 'description': 'Number and severity of TEAEs as assessed by CTCAE 5.0'}, {'measure': 'Frequency and severity of treatment related adverse events (TRAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]', 'timeFrame': 'Treatment Period (Approximately 18 months)', 'description': 'Number and severity of TRAEs as assessed by CTCAE 5.0'}, {'measure': 'Frequency and severity of serious adverse events (SAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]', 'timeFrame': 'Treatment Period (Approximately 18 months)', 'description': 'Number and severity of SAEs as assessed by CTCAE 5.0'}, {'measure': 'Frequency and severity of adverse events leading to dose modifications and/or treatment discontinuation in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]', 'timeFrame': 'Study Treatment Period (Approximately 18 months)', 'description': 'Number and severity of adverse events leading to dose modifications and/or treatment discontinuation as assessed by CTCAE 5.0'}, {'measure': 'Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Objective response rate (ORR)', 'timeFrame': 'Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months)', 'description': 'ORR is defined as the percentage of participants with confirmed complete response (cCR) or confirmed partial response (cPR) per RECIST 1.1'}, {'measure': 'Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Disease control rate (DCR)', 'timeFrame': 'Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months)', 'description': 'DCR is defined as the percentage of participants with no occurrence of progressive disease with either cCR, cPR, or stable disease \\[SD\\] ≥ 16 weeks per RECIST 1.1 from the beginning of study therapy'}, {'measure': 'Preliminary antitumor activity of IK-175 treatment in combination with nivolumab: Duration of response (DOR)', 'timeFrame': 'Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months))', 'description': 'DOR is defined as the time from the first documented CR or PR per RECIST 1.1 until disease progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of IK-175 when administered in combination with nivolumab: half-life (t1/2)', 'timeFrame': 'Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months)', 'description': 'Determine IK-175 half-life (t1/2)'}, {'measure': 'PK of IK-175 when administered in combination with nivolumab: area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months)', 'description': 'Determine IK-175 AUC'}, {'measure': 'PK of IK-175 when administered in combination with nivolumab: maximum serum concentration (Cmax)', 'timeFrame': 'Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months)', 'description': 'Determine IK-175 Cmax'}, {'measure': 'PK of IK-175 when administered in combination with nivolumab: minimum serum concentration (Cmin)', 'timeFrame': 'Time Frame: Day 1, 2, 15 of Cycle 1, Day 1 of Cycles 2-3 (every 28 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 56 days) through end of treatment (approximately 18 months)', 'description': 'Determine IK-175 Cmin'}, {'measure': 'Preliminary antitumor activity of IK-175 in combination with nivolumab: Progression-free survival (PFS) median and at 6 months', 'timeFrame': 'Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 6 months)', 'description': 'PFS is defined as the length of time from the beginning of study treatment to the first observed disease progression or death due to any cause'}, {'measure': 'Preliminary antitumor activity of IK-175 in combination with nivolumab: Overall survival (OS), median and at 6 months', 'timeFrame': 'Through study completion including the Treatment Period (approximately 18 months) and the Follow-Up Period (Up to 12 months)', 'description': 'OS is defined as the length of time from the beginning of study treatment to the date of death due to any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IK-175', 'AHR antagonist', 'AHR inhibitor', 'Aryl Hydrocarbon Receptor Antagonist', 'Immunooncology', 'AHRi', 'Aryl Hydrocarbon Receptor Inhibitor', 'Antagonist', 'Inhibitor', 'anti-PD1', 'aPD1', 'nivolumab', 'checkpoint inhibitor', 'CPI', 'combination therapy'], 'conditions': ['Head and Neck Squamous Cell Carcinoma', 'Head and Neck Cancer', 'Head Cancer', 'Neck Cancer', 'Head Cancer Neck', 'Neck Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* 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.\n* Tumors must express PD-L1 with a minimum CPS ≥ 1.\n* Subjects can be enrolled regardless of their tumor's expression of human papillomavirus (HPV).\n* Subjects are required to have received prior treatment with a platinum-based chemotherapy in the recurrent or metastatic disease setting, unless medically contraindicated.\n* Subject has at least 1 measurable lesion per RECIST v1.1.\n\nKey Exclusion Criteria:\n\n* Subject has untreated or symptomatic central nervous system (CNS) tumors or brain metastases.\n* Subject must have recovered to ≤ Grade 1 from clinically significant AEs related to prior therapy (eg, myelosuppression or renal or hepatic dysfunction.)\n* Subject has received prior treatment with an AHR inhibitor.\n* 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.\n* Uncontrolled or life-threatening symptomatic concomitant disease.\n* Clinically significant cardiovascular disease as defined in the protocol.\n* Subject is on a medication that is a sensitive substrate of CYP2C8, 2C9, 2C19, or 3A4 that cannot be substituted.\n* Females who are pregnant or breastfeeding.\n\nOther inclusion/exclusion criteria are listed in the protocol."}, 'identificationModule': {'nctId': 'NCT05472506', 'briefTitle': 'Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ikena Oncology'}, 'officialTitle': 'A Phase 1b, Open-Label, Single-Arm Dose-Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, in Combination With Nivolumab in Patients With Primary PD-1 Inhibitor Resistant Metastatic or Locally Incurable, Recurrent HNSCC', 'orgStudyIdInfo': {'id': 'IK175-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '600 mg qd PO IK-175 + nivolumab', 'interventionNames': ['Drug: IK-175 + nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '450 mg q12h PO IK-175 + nivolumab', 'interventionNames': ['Drug: IK-175 + nivolumab']}], 'interventions': [{'name': 'IK-175 + nivolumab', 'type': 'DRUG', 'description': 'IK-175 + nivolumab', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Katherine Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ikena Oncology'}, {'name': 'Karim Malek, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ikena Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ikena Oncology', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}