A Study of MG2512 Injection in Participants With Advanced Solid Tumors

NCT07348653 | Not Yet Recruiting Phase 1

• 1 other identifier: MG2512-101
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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)

  From screening period up to study completion, an average of 1 year.

• Maximum plasma Concentration (Cmax)

  From screening period up to study completion, an average of 1 year.

• Area under the curve from zero to time t (AUC0-t)

  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.

Study Arms (1)

MG2512 Injection Group

EXPERIMENTAL

Drug: MG2512 Injection

Interventions

MG2512 Injection DRUG

MG2512 injection.

MG2512 Injection Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent.
• years old, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 3 months.
• 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.
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow reserve and organ function.
• Contraception is required during the trial.

You may not qualify if:

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
• History of other malignant tumors within 5 years before the first use of the study drug.
• Uncontrollable tumor-related pain or symptomatic hypercalcemia.
• Having severe cardiovascular and cerebrovascular diseases.
• Presence of bleeding symptoms with significant clinical significance within 3 months before the first use of the study drug.
• Uncontrollable effusion within 2 weeks before the first use of the study drug.
• Subjects with history of interstitial pneumonia or lung diseases that severely affect lung function.
• Having a severe infection within 4 weeks before the start of study treatment.
• History of immunodeficiency, including positive HIV test results; presence of active hepatitis B.
• Subjects with active pulmonary tuberculosis infection within 1 year before enrollment.
• Adverse reactions from previous antitumor treatment that have not recovered to CTCAE ≤ Grade 1.
• 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.
• Receipt of chest radiotherapy with a dose \> 30 Gy within 24 weeks before the first use of the study drug.
• Subjects with previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
• Subjects with known allergy to any component or excipient of the MG2512 product.

Sponsors & Collaborators

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

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

Rongfu Mao

CONTACT

+86-021-61053363; rongfu.mao@hengrui.com

Hao Shen

CONTACT

+86-021-61053363; hao.shen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (2)