Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-30 @ 2:04 PM
Study NCT ID:
NCT07066657
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity (DLT) - Phase Ia', 'timeFrame': 'Baseline to Day 21 of the first treatment cycle'}, {'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions'}, {'measure': 'Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'AEs that occur or worsen on or after the first dose of study treatment'}, {'measure': 'Treatment-Related Adverse Event', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.'}, {'measure': 'Objective Response Rate (ORR) as assessed by investigator - Phase Ib', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) - Phase Ia', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.'}, {'measure': 'Progression Free Survival (PFS) as assessed by investigator', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to study completion (up to 24 months)', 'description': 'OS is defined as the duration from the start of treatment to death of any cause.'}, {'measure': 'Incidence of anti-drug antibody (ADA)', 'timeFrame': 'Baseline to 30 days after the last dose.', 'description': 'The proportion of patients with positive ADA results.'}, {'measure': 'Incidence of neutralizing antibody (NAb)', 'timeFrame': 'Baseline to 30 days after the last dose.', 'description': 'The proportion of patients with positive NAb results.'}, {'measure': 'Tmax', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Time to reach the maximum blood concentration'}, {'measure': 'Cmax', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Maximum observed blood concentration'}, {'measure': 'AUC0-t', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRG007', 'Advanced or Metastatic Solid Tumors', 'CDH17', 'ARR-217', 'ADC'], 'conditions': ['Locally Advanced or Metastatic Solid Tumors', 'Colorectal Cancer', 'Gastric Cancer', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Willing to sign the informed consent form and follow the requirements specified in the protocol.\n2. Life expectancy ≥ 3 months.\n3. Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.\n4. Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.\n5. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n6. The score of ECOG for performance status is 0 or 1.\n7. Organ functions and coagulation function must meet the basic requirements.\n8. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n1. Patients with more than one cancer.\n2. Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received potent CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives of investigational product, whichever is longer.\n3. ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment\n4. Symptomatic Central nervous system and/or meninges metastasis.\n5. History of severe cardiovascular diseases\n6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3 months prior to the first dose, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis\n7. History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.\n8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion\n9. Infection of active hepatitis B, active hepatitis C, or HIV\n10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment\n11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody.\n12. Other situations that are not suitable to participate a clinical trial per investigator's judgement"}, 'identificationModule': {'nctId': 'NCT07066657', 'briefTitle': 'A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lepu Biopharma Co., Ltd.'}, 'officialTitle': 'An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'MRG007-001/ARR-217-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRG007', 'interventionNames': ['Drug: MRG007']}], 'interventions': [{'name': 'MRG007', 'type': 'DRUG', 'otherNames': ['ARR-217'], 'description': 'MRG007 will be administrated as specified in the protocol.', 'armGroupLabels': ['MRG007']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'ULCA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75039', 'city': 'Irving', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'NEXT Dallas', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Shen, M.D.', 'role': 'CONTACT', 'email': 'doctorshenlin@sina.cn', 'phone': '86-10-88196561'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuying Xiao', 'role': 'CONTACT'}], 'facility': 'Renji Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianshu Liu', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Program Director', 'role': 'CONTACT', 'email': 'clinicaltrials@lepubiopharma.com', 'phone': '86-21-61637960'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lepu Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ArriVent BioPharma, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}