Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 7:06 AM
Study NCT ID:
NCT06898450
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053842', 'term': 'Microsatellite Instability'}, {'id': 'D014898', 'term': 'Werner Syndrome'}], 'ancestors': [{'id': 'D042822', 'term': 'Genomic Instability'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A Primary Objective: Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'The first 21 days of Cycle 1 (Cycle 1 is 28 days).', 'description': 'Assessments will include electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation)'}, {'measure': 'Part A Primary Outcome: • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), according to NCI CTCAE v5.0', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.', 'description': 'Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation.'}, {'measure': 'Part A Primary Outcome: Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events (TRAEs) as assessed by the Investigator', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.', 'description': 'Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).'}, {'measure': 'Part B Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.', 'timeFrame': 'From start of study treatment until end of follow-up, up to approximately 18 months. Each Cycle is 28 days.'}, {'measure': 'Part B Primary Outcome: Duration of Response (DOR) per RECIST v1.1', 'timeFrame': 'From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first; up to approximately 18 months. Each Cycle is 28 days.'}, {'measure': 'Part B Primary Outcome: Incidence and severity of AEs according to NCI CTCAE v5.0.', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug; up to approximately 18 months. Each Cycle is 28 days.', 'description': 'Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).'}, {'measure': 'Part C Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.', 'timeFrame': 'From start of study treatment until end of follow-up, up to approximately 17 months. Each Cycle is 28 days.'}, {'measure': 'Part C Primary Outcome: Duration of Response (DOR) per RECIST v1.1.', 'timeFrame': 'From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first, up to approximately 17 months. Each Cycle is 28 days.'}], 'secondaryOutcomes': [{'measure': 'Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part A Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part A Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part A Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.'}, {'measure': 'Part B Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part B Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part B Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part B Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.'}, {'measure': 'Part C Secondary Objective: Incidence and severity of AEs according to NCI CTCAE v5.0.', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug; up to approximately 17 months. Each Cycle is 28 days.', 'description': 'Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).'}, {'measure': 'Part C Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part C Secondary Objective: Maximum Plasma Concentration Observed (Cmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part C Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}, {'measure': 'Part C Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors', 'Microsatellite Instability', 'Deficient Mismatch Repair', 'Werner syndrome helicase'], 'conditions': ['Advanced Solid Tumors Cancer', 'MSI-H Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.\n\nThe main questions it aims to answer are:\n\nIs NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?\n\nParticipants will:\n\nTake NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.\n\nKeep a diary of their tablet consumption and symptoms experienced.', 'detailedDescription': 'Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Have unresectable and/or metastatic solid tumors (with or without MSI-H/dMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists\n* Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)\n* Adequate bone marrow / hematologic, end-organ, and cardiovascular function\n* Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy).\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease.\n* Patients with known WRN syndrome.\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT06898450', 'briefTitle': 'A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nimbus Therapeutics'}, 'officialTitle': 'A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair', 'orgStudyIdInfo': {'id': '9216-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A dose escalation', 'description': 'Part A Dose Escalation will involve enrolling sequential cohorts with increasing doses of NDI-219216 administered daily in repeating 28-day treatment cycles. The Dose Limiting Toxicity review period for each cohort will be 21 days for each patient enrolled, with review by a Safety Review Committee prior to escalation to the next dose level.', 'interventionNames': ['Drug: NDI-219216']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Project Optimus', 'description': 'Part B will enroll up to 3 cohorts of patients randomized between up to 3 dose levels determined from Part A Dose Escalation. NDI-219216 will be administered daily in repeating 28-day treatment cycles.', 'interventionNames': ['Drug: NDI-219216']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion', 'description': 'Part C will enroll 2 groups of patients with dMMR/MSI-h status and other select criteria, utilizing the optimal dose identified from Part B. NDI-219216 will be administered daily in 28-day repeating cycles.', 'interventionNames': ['Drug: NDI-219216']}], 'interventions': [{'name': 'NDI-219216', 'type': 'DRUG', 'description': 'NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.', 'armGroupLabels': ['Part A dose escalation', 'Part B Project Optimus', 'Part C Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josef Lenz, MD; FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33065', 'city': 'Coral Springs', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sumit Sawhney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Life Clinical Trials', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Moroney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Redman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Louisville James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '14850', 'city': 'Ithaca', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Mato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cayuga Cancer Center', 'geoPoint': {'lat': 42.44063, 'lon': -76.49661}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'R. Wendel Naumann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Nemunaitis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '02901', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benedito Carneiro Filho, MD; MS; PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brown University Health', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Edenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prisma Health Cancer Institute - Multidisciplinary Center', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Reilley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia Emily Couric Clinical Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Spira, MD;PhD;FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Cancer Specialists, P.C. - Fairfax', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Aflah Roohullah, FRACP; MB CHB; PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ganessan Kichenadasse, FRACP; MB BS; MD; PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Oncology Clinical Research Unit', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry Andre, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D07 R2WY', 'city': 'Dublin', 'status': 'NOT_YET_RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Austin Duffy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START Dublin', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '1649-028', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Andre Mansinho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Roberto Martin Huertas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Bartolome, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Sean Rossi', 'role': 'CONTACT', 'email': 'sean.rossi@nimbustx.com', 'phone': '857-600-8779'}, {'name': 'Katie Ard, MSN', 'role': 'CONTACT', 'email': 'katie.ard@nimbustx.com', 'phone': '303-646-7297'}], 'overallOfficials': [{'name': 'Anita Scheuber, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nimbus Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nimbus Wadjet, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}