A Study of MG2512 Injection in Participants With Advanced Solid Tumors

A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of MG2512 Injection in Participants With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: MG2512 Injection

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rongfu Mao; Phone Number: +86-021-61053363; Email: rongfu.mao@hengrui.com
• Study Contact Backup: Name: Hao Shen; Phone Number: +86-021-61053363; Email: hao.shen@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Principal Investigator: Yi Ba
      • Contact: Yi Ba; Phone Number: +86-010- 69158384; Email: bayi@pumch.cn
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital
      • Principal Investigator: Tongyu Lin
      • Contact: Tongyu Lin; Phone Number: +86-028-85420509; Email: tongyulin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG2512 Injection Group	Drug: MG2512 Injection; MG2512 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity (DLT)	3 weeks.
Maximum tolerated dose (MTD)	3 weeks.
Recommended Phase 2 Dose (RP2D)	From screening period up to study completion, an average of 1 year.
Adverse events (AEs)	From screening period up to study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)		From screening period up to study completion, an average of 1 year.
Progression-free survival (PFS)		From screening period up to study completion, an average of 1 year.
Blood concentration of MG2512 after single and continuous administration		From screening period up to study completion, an average of 1 year.
Time to reach maximum plasma concentration (Tmax)	PK parameters of MG2512 after single and continuous administration.	From screening period up to study completion, an average of 1 year.
Maximum plasma Concentration (Cmax)	Pharmacokinetics (PK) parameters of MG2512 after single and continuous administration.	From screening period up to study completion, an average of 1 year.
Area under the curve from zero to time t (AUC0-t)	Pharmacokinetics (PK) parameters of MG2512 after single and continuous administration.	From screening period up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) to MG2512		From screening period up to study completion, an average of 1 year.
Objective response rate (ORR)		From screening period up to study completion, an average of 1 year.
Overall survival (OS)		From screening period up to study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MG2512-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No