Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-25 @ 7:40 AM
Study NCT ID:
NCT07030257
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'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': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Determine the maximum tolerated dose (MTD)', 'timeFrame': '21 days', 'description': 'Determine the MTD of CP-383 in subjects with advanced solid tumors'}, {'measure': 'Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Objective response rate assessed by the investigator according to RECIST'}], 'secondaryOutcomes': [{'measure': 'Part 1: Determine the pharmacokinetics parameters of CP-383', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Assess standard PK parameters including Cmax'}, {'measure': 'Part 1: Determine the pharmacokinetics parameters of CP-383', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Assess standard PK parameters including tmax'}, {'measure': 'Part 1: Determine the pharmacokinetics parameters of CP-383', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Assess standard PK parameters including AUC'}, {'measure': 'Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Incidence and severity of Adverse events and changes in test results'}, {'measure': 'Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Incidence of AEs and changes in test results'}, {'measure': 'Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Evaluate duration of response'}, {'measure': 'Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months'}, {'measure': 'Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Evaluate progression free survival'}, {'measure': 'Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types', 'timeFrame': 'From enrollment through study completion, an average of 1 year', 'description': 'Evaluate overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Dose Escalation', 'Dose Expansion', 'Loss of Function', 'FAT1', 'P300'], 'conditions': ['Solid Tumor Malignancies', 'Colorectal Carcinoma', 'Small Cell Lung Cancer ( SCLC )', 'Head and Neck (HNSCC)', 'Bladder Cancer', 'Non-Small Cell Lung Cancer', 'Pancreatic Cancer, Advanced or Metastatic']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:\n\n* Does CP-383 slow or stop the growth of cancer in patients with advanced cancer\n* What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383\n\nParticipants will:\n\n* Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth\n* Visit the clinic weekly for the first 6 weeks for checkups and tests\n* Visit the clinic every 3 weeks thereafter for checkups and tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Measurable or non measurable cancer that the research can assess for changes\n* Not eligible or able to take existing standard therapies for cancer\n* Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor\n* Diagnosed with locally advanced, recurrent or metastatic incurable disease\n* Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment\n* Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer\n* Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer\n\n \\_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Adequate blood and urine lab tests\n* Women and men of childbearing potential with adequate contraception\n* Provides written informed consent\n* Willing to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Inability to swallow pills\n* Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load\n* Active tumor in the brain\n* Clinically significant liver disease\n* Significant gastrointestinal diseases\n* History of other cancer within past 5 years with certain exceptions for cancers that are likely cured\n* Significant cardiac disease\n* Other diseases that are not well controlled that could make taking the drug unsafe\n* pregnant or lactating females\n* Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug'}, 'identificationModule': {'nctId': 'NCT07030257', 'briefTitle': 'Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasca Therapeutics'}, 'officialTitle': 'A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'TAS-CP383-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'description': 'CP-383, single daily oral capsule, 0.8 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'description': 'CP-383, single daily oral capsule, 1.6 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'description': 'CP-383, single daily oral capsule, 3.0 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'description': 'CP-383, single daily oral capsule, 5.0 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 5', 'description': 'CP-383, single daily oral capsule, 8.0 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 6', 'description': 'CP-383, single daily oral capsule, 12 mg', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm 1', 'description': 'Expansion in selected tumor type at recommended Phase 2 Dose of CP-383', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm 2', 'description': 'Expansion in selected tumor type at recommended Phase 2 Dose of CP-383', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm 3', 'description': 'Expansion in selected tumor type at recommended Phase 2 Dose of CP-383', 'interventionNames': ['Drug: CP-383']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Arm 4', 'description': 'Expansion in selected tumor type at recommended Phase 2 Dose of CP-383', 'interventionNames': ['Drug: CP-383']}], 'interventions': [{'name': 'CP-383', 'type': 'DRUG', 'description': 'Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells', 'armGroupLabels': ['Dose Level 1', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4', 'Dose Level 5', 'Dose Level 6', 'Expansion Arm 1', 'Expansion Arm 2', 'Expansion Arm 3', 'Expansion Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Gilmore', 'role': 'CONTACT', 'email': 'elizabeth.griffith@scri.com', 'phone': '904-380-2410'}, {'name': 'Cesar Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Cancer Specialists-Lake Nona', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Armstrong', 'role': 'CONTACT', 'email': 'colleen.armstrong@startresearch.com', 'phone': '616-389-1905'}, {'name': 'Sreenivasa Chandana, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Servais', 'role': 'CONTACT', 'email': 'aservais@nebraskacancer.com', 'phone': '402-955-2691'}, {'name': 'Ralph Hauke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nebraska Cancer Specialists', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Wall', 'role': 'CONTACT', 'email': 'hwall@carolinabiooncology.org', 'phone': '980-441-1148'}, {'name': 'Neel Gandhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolina BioOncology Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Ambrose, RN, BSN, CCRC', 'role': 'CONTACT', 'email': 'SAmbrose@tcrcpt.org', 'phone': '567-402-4502', 'phoneExt': '7502'}], 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '75039', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mofopefoluwa Akinwale', 'role': 'CONTACT', 'email': 'fakinwale@nextoncology.com', 'phone': '972-893-8800'}, {'name': 'Michael Song, MD, PhD, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel Jimenez', 'role': 'CONTACT', 'email': 'isabel.jimenez@startresearch.com', 'phone': '210-593-5265'}, {'name': 'Kyriakos P. Papadopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84119', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marie Asay', 'role': 'CONTACT', 'email': 'marie.asay@startresearch.com', 'phone': '801-907-4770'}, {'name': 'William McKean, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START Mountain Region', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maybelle De La Rosa', 'role': 'CONTACT', 'email': 'mdelarosa@nextoncology.com', 'phone': '703-783-4518'}, {'name': 'Alexander Spira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Tasca Therapeutics', 'role': 'CONTACT', 'email': 'trials@tascatx.com', 'phone': '617-430-7109'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasca Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}