Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 7:22 PM
Study NCT ID:
NCT05048134
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2021-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Sponsor R\\&D strategy adjustment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose limited toxicity（DLT）', 'timeFrame': 'Cycle 1( 4 weeks- monotherapy；3 weeks -combination）'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'up to 3 years; at least once per treatment cycle'}, {'measure': 'Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy', 'timeFrame': 'through study completion，an average of 2 years', 'description': 'Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-75 years old，Male or female;\n2. Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment;\n3. ECOG PS score of 0-1;\n4. Life expectancy of ≥3 months;\n5. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs \\< 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study;\n2. Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives;\n3. Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied;\n4. Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.'}, 'identificationModule': {'nctId': 'NCT05048134', 'briefTitle': 'A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open-Label，Dose Escalation and Dose Expansion Phase I Study of HRS2300 Monotherapy or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'HRS2300-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'interventionNames': ['Drug: HRS2300']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'interventionNames': ['Drug: HRS2300、 SHR-1316']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group C', 'interventionNames': ['Drug: HRS2300、SHR-1701']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group D', 'interventionNames': ['Drug: HRS2300、trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group E', 'interventionNames': ['Drug: HRS2300、Almonertinib']}], 'interventions': [{'name': 'HRS2300', 'type': 'DRUG', 'description': 'HRS2300 monotherapy', 'armGroupLabels': ['Treatment group A']}, {'name': 'HRS2300、 SHR-1316', 'type': 'DRUG', 'description': 'HRS2300 combined with SHR-1316', 'armGroupLabels': ['Treatment group B']}, {'name': 'HRS2300、SHR-1701', 'type': 'DRUG', 'description': 'HRS2300 combined with SHR-1701', 'armGroupLabels': ['Treatment group C']}, {'name': 'HRS2300、trametinib', 'type': 'DRUG', 'description': 'HRS2300 combined with trametinib', 'armGroupLabels': ['Treatment group D']}, {'name': 'HRS2300、Almonertinib', 'type': 'DRUG', 'description': 'HRS2300 combined with Almonertinib', 'armGroupLabels': ['Treatment group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}