Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT05887492
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the MTD and RP2D(s) (Phase 1 only)', 'timeFrame': '42 days', 'description': 'To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab'}, {'measure': 'Measure antitumor activity using RECIST 1.1 (Phase 2 only)', 'timeFrame': '12 weeks', 'description': 'To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'Measure antitumor evidence of TNG260 + pembrolizumab antineoplastic activity by RECIST 1.1 (Phase 1 only)', 'timeFrame': '12 weeks', 'description': 'To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1'}, {'measure': 'Characterize Area Under the Curve (AUC) of TNG260', 'timeFrame': '37 days', 'description': 'Measure the plasma concentration versus time curve (AUC) of TNG260 alone and when administered in combination with pembrolizumab'}, {'measure': 'Characterize the time to achieve Time to Maximal Concentration (Tmax) of TNG260', 'timeFrame': '37 days', 'description': 'To characterize the Tmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab'}, {'measure': 'Characterize Maximum Observed Plasma Concentration (Cmax) of TNG260', 'timeFrame': '37 days', 'description': 'To characterize the Cmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab'}, {'measure': 'Characterize Terminal Half-life (T1/2) of TNG260', 'timeFrame': '37 days', 'description': 'To characterize the T1/2 by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab'}, {'measure': 'Characterize pembrolizumab concentrations when administered with TNG260', 'timeFrame': '43 days', 'description': 'To characterize the pre treatment and trough concentration levels of pembrolizumab when administered in combination with TNG260'}, {'measure': 'Safety and tolerability of TNG260 by CTCAE 5.0', 'timeFrame': '42 days', 'description': 'To evaluate the safety and tolerability of TNG260 when administered as single agent and in combination with pembrolizumab by measuring the incidence, nature, and severity of AE and SAE graded according to CTCAE v5.0'}, {'measure': 'To measure changes in histone acetylation when administered with TNG260', 'timeFrame': '12 weeks', 'description': 'Measure changes in levels of histone acetylation in blood and/or tumor tissue, on study treatment relative to pre-treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STK11', 'KRAS wild type', 'LKB1'], 'conditions': ['Non Small Cell Lung Cancer', 'Solid Tumors, Adult', 'Lung Cancer', 'Lung Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.\n\nThe main question\\[s\\] it aims to answer are:\n\n* the recommended dose for Phase 2\n* to evaluate the safety and tolerability of the combination therapy\n* to determine the pharmacokinetics of TNG260\n* to evaluate the initial antineoplastic activity\n\nParticipants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.', 'detailedDescription': 'This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is ≥18 years of age at the time of signature of the main study ICF.\n* Has ECOG performance status of 0 or 1.\n* Has measurable disease based on RECIST v1.1.\n* All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method\n* Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor.\n* Adequate organ function/reserve per local labs\n* Adequate liver function per local labs\n* Adequate renal function per local labs\n* Negative serum pregnancy test result at screening\n* Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients\n* Uncontrolled intercurrent illness that will limit compliance with the study requirements\n* Active infection requiring systemic therapy\n* Currently participating in or has planned participation in a study of another investigational agent or device\n* Impairment of GI function or disease that may significantly alter the absorption of oral TNG260\n* Active prior or concurrent malignancy.\n* Central nervous system metastases associated with progressive neurological symptoms\n* Current active liver disease from any cause\n* Clinically relevant cardiovascular disease\n* A female patient who is pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT05887492', 'briefTitle': 'Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tango Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'TNG260-C101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD', 'interventionNames': ['Drug: TNG260', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion in NSCLC with KRAS Mutation', 'description': 'Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab', 'interventionNames': ['Drug: TNG260', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion in NSCLC with KRAS Wild type', 'description': 'Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab', 'interventionNames': ['Drug: TNG260', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion in Advanced or Metastatic Solid Tumors', 'description': 'Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab', 'interventionNames': ['Drug: TNG260', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'TNG260', 'type': 'DRUG', 'description': 'CoREST inhibitor, administered orally', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion in Advanced or Metastatic Solid Tumors', 'Dose Expansion in NSCLC with KRAS Mutation', 'Dose Expansion in NSCLC with KRAS Wild type']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Keytruda'], 'description': 'Pembrolizumab, an anti-PD-1 antibody, administered intravenously', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion in Advanced or Metastatic Solid Tumors', 'Dose Expansion in NSCLC with KRAS Mutation', 'Dose Expansion in NSCLC with KRAS Wild type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Goldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA Hematology/Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gerald Falchook, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SCRI at HealthOne', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Judy Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Awad, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shiresh Gadgeel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Manish Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START MidWest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Salman Punekar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Hematology Oncology Associates-Mineola', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Salman Punekar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Spigel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarah Cannon Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kartik Konduri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'US Oncology Investigational Products Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ferdinandos Skoulidis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Spira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jedrzej Wykretowicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'US Oncology Investigational Products Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'centralContacts': [{'name': 'Adam Crystal, MD, PhD', 'role': 'CONTACT', 'email': 'clinicaltrials@tangotx.com', 'phone': '8573204899'}], 'overallOfficials': [{'name': 'Adam Crystal, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tango Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tango Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}