Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-20 @ 1:35 PM
Study NCT ID:
NCT05315167
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2022-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D of PRJ1-3024 .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 267}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period', 'timeFrame': 'Day 1 to Day 21', 'description': 'Safety listings and pharmacokinetic listings will be used for evaluation'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': '24 months', 'description': 'Characterized by type, seriousness, relationship to study treatment, timing, and severity.'}, {'measure': 'Pharmacokinetic parameter# Accumulation ratio', 'timeFrame': '24 months', 'description': 'to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '24 months', 'description': 'estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '24 months', 'description': 'defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.'}, {'measure': 'Pharmacokinetic parameter#AUC0-last#', 'timeFrame': '24 months', 'description': 'Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration'}, {'measure': 'Pharmacokinetic parameter#Maximum observed concentration (Cmax)', 'timeFrame': '24 months', 'description': 'assessed as time from time 0 to the time of the last quantifiable concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maximum tolerated dose', 'Recommended Phase 2 dose', 'Dose Escalation', 'Hematopoietic progenitor kinase 1', 'PRJ1-3024'], 'conditions': ['Advanced Solid Tumor', 'Advanced Solid Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.', 'detailedDescription': 'Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.\n\nParticipants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.\n\nThis study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '\\- Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.\n* Male or non-pregnant, non-lactating female subjects age ≥18 years.\n* ECOG Performance Status 0\\~1.\n* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .\n* Life expectancy of \\>3 months, in the opinion of the Investigator.\n* Able to take oral medications and willing to record daily adherence to investigational product.\n* Adequate hematologic parameters unless clearly due to the disease under study.\n* Adequate renal and hepatic function\n* Able to understand and willing to sign a written informed consent form.\n\nKey Exclusion Criteria:\n\n* History of another malignancy\n* Known symptomatic brain metastases requiring \\>10 mg/day of prednisolone.\n* Significant cardiovascular disease.\n* Known active HBV, HCV, AIDS-related illness.\n* Has received a live vaccine within 30 days.\n* History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing .\n* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \\< Grade 2.\n* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .\n* Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.'}, 'identificationModule': {'nctId': 'NCT05315167', 'briefTitle': 'A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhuhai Yufan Biotechnologies Co., Ltd'}, 'officialTitle': 'A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PRJ1-3024-001'}, 'secondaryIdInfos': [{'id': 'CXHL2101725', 'type': 'OTHER', 'domain': 'CDE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy Escalation', 'description': '3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.', 'interventionNames': ['Drug: PRJ1-3024']}, {'type': 'EXPERIMENTAL', 'label': 'Monotherapy Exploration of the recommended dose', 'description': 'Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.', 'interventionNames': ['Drug: PRJ1-3024']}], 'interventions': [{'name': 'PRJ1-3024', 'type': 'DRUG', 'description': 'PRJ1-3024 is provided as capsules and is administered orally once a day.', 'armGroupLabels': ['Monotherapy Escalation', 'Monotherapy Exploration of the recommended dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanru Qin', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongsheng Wang', 'role': 'CONTACT'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ji Zhu', 'role': 'CONTACT'}], 'facility': 'Cancer hospital of the University of Chinese Academy of Sciences', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Shen, Dr.', 'role': 'CONTACT', 'email': 'doctorshenlin@sina.com', 'phone': '8610-88196561'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanghai Dai', 'role': 'CONTACT'}], 'facility': 'The Fifth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liting Lai', 'role': 'CONTACT', 'email': 'vivi.lai@ming-med.com', 'phone': '8617728075858'}], 'overallOfficials': [{'name': 'Hui ouyang, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuhai Yufan Biotechnologies Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}