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

NCT07032298 | Recruiting Phase 1

• 1 other identifier: SSGJ-612-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Adverse Events (AEs)

  Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.

  Through study completion, an average of 1 year

• Incidence of DLT

  Dose-Limiting Toxicity

  14 days

Secondary Outcomes (13)

• ORR assessed by investigators per RECIST v1.1

  Through study completion, an average of 1 year

• DoR assessed by investigators per RECIST v1.1

  Through study completion, an average of 1 year

• DCR assessed by investigators per RECIST v1.1

  Through study completion, an average of 1 year

• TTR assessed by investigators per RECIST v1.1

  Through study completion, an average of 1 year

• PFS

  Through study completion, an average of 1 year

Study Arms (1)

SSGJ-612

EXPERIMENTAL

In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded.

Drug: SSGJ-612

Interventions

SSGJ-612 DRUG

Intravenous injection

SSGJ-612

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

RECRUITING

Central Study Contacts

Jun Yao, M.D.

CONTACT

13663790098; yaojun74@163.com

Cai'e Wang, M.D.

CONTACT

13837915297; 2454544618@qq.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: June 19, 2025
• First Posted: June 23, 2025
• Study Start: July 18, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)