Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:22 AM
Study NCT ID:
NCT06179160
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'C480833', 'term': 'IFL protocol'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 710}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.'}, {'measure': 'Number of participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 2 years and 90 days', 'description': 'Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.'}, {'measure': 'Number of participants with TEAEs leading to dose modification or discontinuation', 'timeFrame': 'Up to 2 years and 90 days', 'description': 'Number of participants with TEAEs leading to dose modification or discontinuation.'}], 'secondaryOutcomes': [{'measure': 'INCB161734 pharmacokinetic (PK) in Plasma', 'timeFrame': 'Up to approximately 90 days', 'description': 'INCB161734 concentration in plasma.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.'}, {'measure': 'Disease Control Response (DCR)', 'timeFrame': 'Up to 2 years', 'description': 'Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB161734', 'KRASG12D Mutation', 'pancreatic ductal adenocarcinoma (PDAC)', 'colorectal cancer (CRC)', 'non-small cell lung cancer (NSCLC)'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://incyteclinicaltrials.com/studies/incb161734-101', 'label': 'A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old.\n* Locally advanced or metastatic solid tumor with KRAS G12D mutation.\n* For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.\n* Cohort specific requirements aas defined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Prior treatment with any KRAS G12D inhibitor\n* Known additional invasive malignancy within 1 year of the first dose of study drug\n* History of organ transplant, including allogeneic stem cell transplantation\n* Significant, uncontrolled medical condition\n* History or presence of an ECG abnormality\n* Inadequate organ function\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply'}, 'identificationModule': {'nctId': 'NCT06179160', 'briefTitle': 'A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation', 'orgStudyIdInfo': {'id': 'INCB161734-101'}, 'secondaryIdInfos': [{'id': '2023-507091-47-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a: Dose Escalation monotherapy', 'description': 'INCB161734 at the protocol-defined dose strength based on cohort assignment.', 'interventionNames': ['Drug: INCB161734']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1b: Dose Expansion monotherapy', 'description': 'INCB161734 at the protocol-defined dose strength based on cohort assignment.', 'interventionNames': ['Drug: INCB161734']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1c: Pharmacodynamic cohort', 'description': 'INCB161734 at the protocol-defined dose strength based on cohort assignment.', 'interventionNames': ['Drug: INCB161734']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2a: Dose Escalation combination', 'description': 'INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.', 'interventionNames': ['Drug: INCB161734', 'Drug: Cetuximab', 'Drug: Retifanlimab', 'Drug: GEMNabP', 'Drug: mFOLFIRINOX', 'Drug: FOLFOX', 'Drug: FOLFIRI', 'Drug: INCA33890']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2b: Dose Expansion combination', 'description': 'INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.', 'interventionNames': ['Drug: INCB161734', 'Drug: Cetuximab', 'Drug: Retifanlimab', 'Drug: GEMNabP', 'Drug: mFOLFIRINOX', 'Drug: FOLFOX', 'Drug: FOLFIRI', 'Drug: INCA33890']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1d: Food-Effect', 'description': 'Evaluate food effect on drug exposure as defined in the protocol.', 'interventionNames': ['Drug: INCB161734']}], 'interventions': [{'name': 'INCB161734', 'type': 'DRUG', 'description': 'INCB161734 will be administered at protocol defined dose.', 'armGroupLabels': ['Part 1a: Dose Escalation monotherapy', 'Part 1b: Dose Expansion monotherapy', 'Part 1c: Pharmacodynamic cohort', 'Part 1d: Food-Effect', 'Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Cetuximab will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'Retifanlimab', 'type': 'DRUG', 'description': 'Retifanlimab will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'GEMNabP', 'type': 'DRUG', 'description': 'GEMNabP will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'mFOLFIRINOX', 'type': 'DRUG', 'description': 'mFOLFIRINOX will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'FOLFOX', 'type': 'DRUG', 'description': 'FOLFOX will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'FOLFIRI', 'type': 'DRUG', 'description': 'FOLFIRI will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}, {'name': 'INCA33890', 'type': 'DRUG', 'description': 'INCA33890 will be administered at protocol defined dose.', 'armGroupLabels': ['Part 2a: Dose Escalation combination', 'Part 2b: Dose Expansion combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Healthcare Hematology-Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institue At Healthone', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 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'facility': 'Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Quironsalud Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Incyte Corporation Call Center (US)', 'role': 'CONTACT', 'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463'}, {'name': 'Incyte Corporation Call Center (ex-US)', 'role': 'CONTACT', 'email': 'eumedinfo@incyte.com', 'phone': '+800 00027423'}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}