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

StatusRecruiting
PhasePhase 1/2
Started2025-09-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from Jiangsu HengRui Medicine Co., Ltd.

Amendment history

2026-09-01
critical
Study Status, Contacts/Locations v1
Primary endpoint(s) modified1 to 3 entries
WasObjective Response Rate (ORR)
NowIncidence and severity of adverse events (AEs) / serious adverse events (SAEs), Objective Response Rate (ORR), Recommended Phase II dose (RP2D)
Interventions modified
Recruitment opened
Start dateestimated 2025-08→confirmed 2025-09-23
Study sitesdetails revised at 2 of 2 sites
2025-08-21
minor
Original filing
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.
Trial Details
NCT Number NCT07136142
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Malignant Solid Tumor
Enrollment 150 participants
Start Date 2025-09-23
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-23