NCT07348653 A Study of MG2512 Injection in Participants With Advanced Solid Tumors
| NCT ID | NCT07348653 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Mabgen Biopharmaceutical Technology Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 116 participants in total. It began in 2026-03-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of MG2512 injection in participants with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation and written informed consent. 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: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07348653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07348653 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07348653 currently recruiting?
Yes, NCT07348653 is actively recruiting participants. Contact the research team at rongfu.mao@hengrui.com for enrollment information.
Where is the NCT07348653 trial being conducted?
This trial is being conducted at Beijing, China, Chengdu, China.
Who is sponsoring the NCT07348653 clinical trial?
NCT07348653 is sponsored by Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.. The trial plans to enroll 116 participants.