Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT06949761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'from first dose to 90 days after last dose', 'description': 'any untoward medical occurrence in a subject who received an investigational product, which can be manifested as any symptoms, signs, diseases, or laboratory test abnormalities, and do not necessarily have a causal relationship with the investigational product'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation.\n\nThe study includes Phase Ib (combination therapy with dose escalation stage) and Phase II (expansion stage). The study will includes a total of 4 cohorts:\n\nPhase Ib will enroll subjects in 4 cohorts (cohorts 1-4). Subjects will be allocated to appropriate cohorts by the investigator according to specific indications and treated with the corresponding combination regimen for safety and tolerability assessment. The Bayesian optimal interval (BOIN) design will be used for dose escalation and MTD determination.\n\nIn Phase II, according to the results of the Phase Ib and SMC decision, 1-2 appropriate dose groups will be selected. In the dose group(s), the sample size (including subjects in the dose escalation stage) will be increased to 20 for each indication according to the cohort for expansion to further evaluate the efficacy of QLC1101 combination therapy in the treatment of subjects with advanced solid tumors harboring KRAS G12D mutations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.\n* Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy\n* The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1\n* ECOG PS score: 0 or 1\n\nExclusion Criteria:\n\n* Subjects who have been previously treated with inhibitors for KRAS G12D mutations\n* Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study\n* Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening'}, 'identificationModule': {'nctId': 'NCT06949761', 'briefTitle': 'A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation', 'orgStudyIdInfo': {'id': 'QLC1101-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLC1101+QL1203', 'interventionNames': ['Drug: QLC1101+QL1203']}, {'type': 'EXPERIMENTAL', 'label': 'QLC1101+QL2107', 'interventionNames': ['Drug: QLC1101+QL2107']}, {'type': 'EXPERIMENTAL', 'label': 'QLC1101+QL1706', 'interventionNames': ['Drug: QLC1101+QL1706']}, {'type': 'EXPERIMENTAL', 'label': 'QLC1101+docetaxel', 'interventionNames': ['Drug: QLC1101+docetaxel']}], 'interventions': [{'name': 'QLC1101+QL1203', 'type': 'DRUG', 'description': 'QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.；QL1203, developed by Qilu Pharmaceutical Co., Ltd., is a recombinant anti-EGFR fully human monoclonal antibody injection and a biosimilar to Vectibix®', 'armGroupLabels': ['QLC1101+QL1203']}, {'name': 'QLC1101+QL2107', 'type': 'DRUG', 'description': 'QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.；QL2107 developed by Qilu Pharmaceutical Co., Ltd. is a potential biosimilar to Pembrolizumab (Keytruda®)', 'armGroupLabels': ['QLC1101+QL2107']}, {'name': 'QLC1101+QL1706', 'type': 'DRUG', 'description': 'QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.；QL1706 Injection (QL1706) is a combination antibody developed by Qilu Pharmaceutical Co., Ltd. It consists of two full-length immunoglobulin G (IgG) antibodies: anti-PD-1 monoclonal antibody (hereafter referred to as anti-PD-1) and anti-CTLA-4 monoclonal antibody (hereafter referred to as anti-CTLA-4)', 'armGroupLabels': ['QLC1101+QL1706']}, {'name': 'QLC1101+docetaxel', 'type': 'DRUG', 'description': 'QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.；Docetaxel is a tubulin binding agent that prevents cell division by stabilizing microtubule structure and leads to apoptosis', 'armGroupLabels': ['QLC1101+docetaxel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'caicun Zhou, PhD', 'role': 'CONTACT', 'email': 'caicunzhoudr@163.com', 'phone': '13301825532'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}