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
Condition(s) studied
Malignant Solid Tumor
Investigational drug(s) / intervention(s)
FH-006 for Injection: FH-006 for injection.
SHR-1316 Injection: SHR-1316 Injection.
Paclitaxel for Injection (Albumin-Bound): Paclitaxel for Injection (Albumin-Bound).
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
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)
- Objective Response Rate (ORR) — Assessed up to 6 months.
ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors. - Recommended Phase II dose (RP2D) — From the first dose of study medication up to 28 days.
- Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) — From signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors
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Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
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GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
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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