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Recruiting NCT07032298

A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Malignant Tumors

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: SSGJ-612.
Who it may be relevant to
Registry conditions: Advanced Malignant Tumors. 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

Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors

Overview

This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.

Detailed description

The clinical trial consists of two phases. In the dose escalation stage, the accelerated titration method combined with the traditional "3+3" design will be adopted, to evaluate the safety and dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or the maximum dose of administration (MAD). In the dose expansion phase, several safe and effective dose levels of SSGJ-612 will be expanded and further evaluated in larger groups of participants.

Interventions

  • Drug SSGJ-612
    Intravenous injection

Primary outcome measures

  • Incidence and severity of Adverse Events (AEs) [Time frame: Through study completion, an average of 1 year]
  • Incidence of DLT [Time frame: 14 days]
Secondary outcome measures (12)
  • ORR assessed by investigators per RECIST v1.1 [Time frame: Through study completion, an average of 1 year]
  • DoR assessed by investigators per RECIST v1.1 [Time frame: Through study completion, an average of 1 year]
  • DCR assessed by investigators per RECIST v1.1 [Time frame: Through study completion, an average of 1 year]
  • TTR assessed by investigators per RECIST v1.1 [Time frame: Through study completion, an average of 1 year]
  • PFS [Time frame: Through study completion, an average of 1 year]
  • OS [Time frame: Through study completion, an average of 1 year]
  • Cmax of SSGJ-612 [Time frame: Through study completion, an average of 1 year]
  • Cmin of SSGJ-612 [Time frame: Through study completion, an average of 1 year]
  • Tmax of SSGJ-612 [Time frame: Through study completion, an average of 1 year]
  • T1/2 of SSGJ-612 [Time frame: Through study completion, an average of 1 year]
  • AUC0-last [Time frame: Through study completion, an average of 1 year]
  • Incidence of ADA and Nab [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
  • Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
  • Expected survival ≥3 months;
  • Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
  • Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy;
  • Tumor tissue with HER2 expression;
  • At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.

Exclusion criteria

  • Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
  • Presence of active central nervous system (CNS) metastatic lesions;
  • Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
  • Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
  • Known active tuberculosis; known active syphilis infection;
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study;
  • Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;
  • Pregnant or lactating women.

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 · 1 center
  • The First Affiliated Hospital of Henan University of Science & Technology — Luoyang

Identifiers

NCT: NCT07032298 · SSGJ-612-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗