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Clinical Trials in China / NCT07136142
Recruiting Phase 1/2

A Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

NCT07136142 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 1/2
Started
2025-09-23
Last updated
2026-09-04

Condition(s) studied

Malignant Solid Tumor

Investigational drug(s) / intervention(s)

FH-006 for Injection

FH-006 for Injection: FH-006 for injection.

Study summary

This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study. 2. Patients with unresectable recurrent or metastatic solid tumors. 3. There is at least one lesion that could be measured. 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 5. Adequate organ functions as defined. 6. Life expectancy ≥ 3 months. Exclusion Criteria: 1. Patients with known active central nervous system (CNS) metastases. 2. Subjects who had other malignancy in five years before the first dose. 3. Patients with tumor-related pain that can not be controlled as determined. 4. Patients with serious cardiovascular and cerebrovascular diseases. 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion. 6. Patients with severe infections. 7. History of immunodeficiency. 8. History of autoimmune diseases. 9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy. 10. Active infection. 11. Pregnant or nursing women. 12. Known history of serious allergic reactions to the investigational product or its main ingredients.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Tianjin Medical Unversity Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07136142 on ClinicalTrials.gov ↗ ← All trials in China