Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:45 PM
Study NCT ID:
NCT07380334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of dose-limiting toxicity (DLT).', 'timeFrame': 'Expected results within one year.', 'description': "The first dosing cycle after each subject's enrollment is the DLT observation period."}, {'measure': 'Adverse events (AEs).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "Continuous observation from each participant's knowledge until the end of the safety follow-up period."}, {'measure': 'Serious adverse events (SAEs).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "Continuous observation from each participant's knowledge until the end of the safety follow-up period."}, {'measure': 'Maximum tolerated dose (MTD).', 'timeFrame': 'Plan to obtain results within 10 months of the first dose ramp up.', 'description': 'Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.'}, {'measure': 'Recommended dose for phase II clinical study (RP2D).', 'timeFrame': 'Plan to obtain results within 20 months of the first dose ramp up.', 'description': 'Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) indicator - Blood drug concentration.', 'timeFrame': 'The plan is to complete all evaluations within 2 years.', 'description': 'The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The PK evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.'}, {'measure': 'Immunogenic indicator - Anti-drug antibody (ADA) levels.', 'timeFrame': 'The plan is to complete all evaluations within 2 years.', 'description': 'The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The ADA evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.'}, {'measure': 'Effectiveness indicator - Researchers evaluated objective response rate (ORR).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress."}, {'measure': 'Effectiveness indicator - Researchers evaluated duration of response (DoR).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress."}, {'measure': 'Effectiveness indicator - Researchers evaluated disease control rate (DCR).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress."}, {'measure': 'Effectiveness indicator - Researchers evaluated progression free survival (PFS).', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress."}, {'measure': 'Effectiveness indicator - Researchers evaluated overall survival (OS) based on the RECIST v1.1 evaluation criteria for solid tumor treatment efficacy.', 'timeFrame': 'Approximately 12 months after the last patient enrolled.', 'description': "After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, open label, dose exploration/efficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;\n2. Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;\n3. Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;\n4. Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;\n5. Able to provide sufficient fresh or archived tumor tissue specimens for third-party central laboratories designated by the sponsor to test expression levels; For participants who are unable to provide tumor tissue samples, the decision to enroll will be made after joint evaluation by the researchers and the sponsor;\n6. At least one measurable lesion that meets RECIST v1.1 criteria; Lesions that have undergone local treatment, if there is clear evidence of significant progression after treatment, can be selected as target lesions;\n7. ECOG PS score: 0 to 1;\n8. Expected survival period ≥ 12 weeks;\n9. The function of important organs meets the requirements;\n10. Female participants with fertility must have a negative serum HCG test within 7 days prior to their first medication and must be non lactating; Female participants with fertility must agree to use contraception and avoid egg donation for a period of 7 months from the signing of the informed consent form until the last administration of the investigational drug; Male participants whose partners are fertile women must agree to contraception and avoid donating sperm for a period of 4 months from the signing of the informed consent form until the last administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;\n2. Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;\n3. Previous or concurrent presence of other malignant tumors;\n4. Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;\n5. Interstitial pneumonia/interstitial lung disease, non infectious pneumonia (such as radiation pneumonitis) that previously required steroid treatment; Currently present or suspected of having interstitial pneumonia/interstitial lung disease, non infectious pneumonia, or other active pneumonia; Severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other lung damage occurred within 6 months prior to the first use of medication; Individuals with active pulmonary tuberculosis;\n6. Accompanied by poorly controlled or severe cardiovascular disease;\n7. Within one month prior to the first medication, there has been a bleeding event with NCI-CTCAE v5.0 grade ≥ 2;\n8. Those who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess within 3 months before the first medication;\n9. Symptoms and signs of gastrointestinal obstruction or gastrointestinal obstruction within 3 months prior to the first use of medication;\n10. Participants who have experienced a severe infection within one month prior to their first medication;\n11. History of immunodeficiency, including HIV test positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Participants known to have active hepatitis or active hepatitis C;\n12. Patients who have previously undergone surgery (excluding diagnostic surgery), radiotherapy, local treatment, chemotherapy, macromolecular targeted therapy, anti-tumor immunotherapy, and have completed treatment (last medication) less than 4 weeks after the first medication; Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) with less than 5 half lives or 4 weeks (whichever is shorter) between the last dose and the first dose;\n13. Previously received drug treatment with the same mechanism as the experimental drug;\n14. According to NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor therapy has not yet recovered to ≤ grade 1;\n15. Individuals known to be allergic to any component or other antibody drugs of SHR-1049 product;\n16. Those who have received attenuated live vaccine within 4 weeks before the first administration or are likely to receive attenuated live vaccine during treatment and within 60 days after the last administration;\n17. According to the researcher's judgment, there are other factors that may affect the research results or force the termination of this study midway."}, 'identificationModule': {'nctId': 'NCT07380334', 'briefTitle': 'A Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 Injection in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-1049-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 1', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 2', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 3', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 4', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 5', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1049 Group - Queue 6', 'description': 'Specified dose on specified days.', 'interventionNames': ['Drug: SHR-1049 Injection']}], 'interventions': [{'name': 'SHR-1049 Injection', 'type': 'DRUG', 'description': 'SHR-1049 injection.', 'armGroupLabels': ['SHR-1049 Group - Queue 1', 'SHR-1049 Group - Queue 2', 'SHR-1049 Group - Queue 3', 'SHR-1049 Group - Queue 4', 'SHR-1049 Group - Queue 5', 'SHR-1049 Group - Queue 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Tingbo Liang', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '+86-0571-87236688'}, {'name': 'Xueli Bai', 'role': 'CONTACT', 'email': 'shirleybai@zju.edu.cn', 'phone': '+86-0571-87236857'}, {'name': 'Tingbo Liang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xueli Bai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Peng Xiu', 'role': 'CONTACT', 'email': 'peng.xiu@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}