A Study of MG2512 Injection in Participants With Advanced Solid Tumors
Recruiting
Phase 1Interventional Study
Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
116 (estimated)
Sponsor
Shanghai Mabgen Biopharmaceutical Technology Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors that can't be cured with standard treatments. Participants will receive MG2512 injection and help researchers understand its safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outActive hepatitis BHIV positiveActive pulmonary tuberculosis
You may be able to join if
I am between 18 and 75 years old.
I can provide written consent to participate.
I have advanced solid tumors that have progressed after standard treatment.
I have at least one measurable tumor.
I expect to live for at least 3 months.
I have a good performance status and can take part in the trial.
I can provide tumor tissue for testing.
I will use contraception during the trial.
You may not be able to join if
I have a history of brain metastasis or related symptoms.
I have had another cancer in the last 5 years.
I have severe heart or blood vessel diseases.
I have uncontrolled pain or symptoms from my tumor.
I have had severe infections in the past month.
I have a serious lung disease that affects my breathing.
I had any major bleeding in the last 3 months.
I cannot wait 4 weeks after my last cancer treatment before starting this trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 o…
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.
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