A Study of MG2512 Injection in Participants With Advanced Solid Tumors
NCT ID: NCT07348653
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
116 participants
INTERVENTIONAL
2026-02-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MG2512 Injection Group
MG2512 Injection
MG2512 injection.
Interventions
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MG2512 Injection
MG2512 injection.
Eligibility Criteria
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Inclusion Criteria
2. 18-75 years old, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Patients with recurrent or metastatic solid tumors that have been histologically or cytologically confirmed to be incurable through surgery or radical radiotherapy and chemotherapy, who have experienced disease progression after standard treatment, or have no standard treatment plan, or are not suitable for standard treatment.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow reserve and organ function.
9. Contraception is required during the trial.
Exclusion Criteria
2. History of other malignant tumors within 5 years before the first use of the study drug.
3. Uncontrollable tumor-related pain or symptomatic hypercalcemia.
4. Having severe cardiovascular and cerebrovascular diseases.
5. Presence of bleeding symptoms with significant clinical significance within 3 months before the first use of the study drug.
6. Uncontrollable effusion within 2 weeks before the first use of the study drug.
7. Subjects with history of interstitial pneumonia or lung diseases that severely affect lung function.
8. Having a severe infection within 4 weeks before the start of study treatment.
9. History of immunodeficiency, including positive HIV test results; presence of active hepatitis B.
10. Subjects with active pulmonary tuberculosis infection within 1 year before enrollment.
11. Adverse reactions from previous antitumor treatment that have not recovered to CTCAE ≤ Grade 1.
12. Failure to meet the following requirements for previous treatment washout: receipt of anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, or other non-marketed investigational drug treatments within 4 weeks before the first use of the study drug.
13. Receipt of chest radiotherapy with a dose \> 30 Gy within 24 weeks before the first use of the study drug.
14. Subjects with previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
15. Subjects with known allergy to any component or excipient of the MG2512 product.
16. Subjects with other factors that may affect the study results or lead to forced premature termination of the study, as judged by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MG2512-101
Identifier Type: -
Identifier Source: org_study_id
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