Menu
Recruiting NCT07348653

A Study of MG2512 Injection in Participants With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MG2512 Injection.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug MG2512 Injection
    MG2512 injection.

Primary outcome measures

  • Dose limiting toxicity (DLT) [Time frame: 3 weeks.]
  • Maximum tolerated dose (MTD) [Time frame: 3 weeks.]
  • Recommended Phase 2 Dose (RP2D) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Adverse events (AEs) [Time frame: From screening period up to study completion, an average of 1 year.]
Secondary outcome measures (9)
  • Blood concentration of MG2512 after single and continuous administration [Time frame: From screening period up to study completion, an average of 1 year.]
  • Time to reach maximum plasma concentration (Tmax) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Maximum plasma Concentration (Cmax) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Area under the curve from zero to time t (AUC0-t) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Drug Resistant Antibody (ADA) to MG2512 [Time frame: From screening period up to study completion, an average of 1 year.]
  • Objective response rate (ORR) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Disease control rate (DCR) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Progression-free survival (PFS) [Time frame: From screening period up to study completion, an average of 1 year.]
  • Overall survival (OS) [Time frame: From screening period up to study completion, an average of 1 year.]

Eligibility criteria

Inclusion criteria

  • Voluntary participation and written informed consent.
  • 18-75 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.

Exclusion criteria

  • 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.
  • Subjects with other factors that may affect the study results or lead to forced premature termination of the study, as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Peking Union Medical College Hospital — Beijing
  • Sichuan Cancer Hospital — Chengdu

Identifiers

NCT: NCT07348653 · MG2512-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗