FH-006 injection study for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional, multi-phase (Phase 1/2) study evaluating FH-006 for injection in adults with malignant solid tumors. It will assess safety, tolerability, pharmacokinetics, and immunogenicity, along with preliminary signs of efficacy. Patients may receive FH-006 alongside SHR-1316 and paclitaxel, with careful monitoring for adverse events and responses. Eligible participants have good performance status, measurable disease, and adequate organ function, while those with active CNS metastases or certain other conditions are excluded. The study is led by Jiangsu HengRui Medicine and conducted at two major cancer centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin Medical Unversity Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Zhenqun Lu
• Email: zhenqun.lu@hengrui.com
• Phone: +86-0518-81220121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.