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

NCT07136142 | Not Yet Recruiting Phase 1

• 1 other identifier: FH-006-102
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors.

  Assessed up to 6 months.

Secondary Outcomes (6)

• Time to maximum concentration (Tmax)

  Up to 2 years.

• Maximum concentration (Cmax)

  Up to 2 years.

• Terminal half-life (t1/2)

  Up to 2 years.

• Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t)

  Up to 2 years.

• Adverse events (AEs)

  Up to 24 weeks.

Study Arms (1)

FH-006 Group

EXPERIMENTAL

FH-006 for injection monotherapy should be conducted.

Drug: FH-006 for Injection

Interventions

FH-006 for Injection DRUG

FH-006 for injection.

FH-006 Group

Eligibility Criteria

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

You may qualify if:

• Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.
• Patients with unresectable recurrent or metastatic solid tumors.
• There is at least one lesion that could be measured.
• An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
• Adequate organ functions as defined.
• Life expectancy ≥ 3 months.

You may not qualify if:

• Patients with known active central nervous system (CNS) metastases.
• Subjects who had other malignancy in five years before the first dose.
• Patients with tumor-related pain that can not be controlled as determined.
• Patients with serious cardiovascular and cerebrovascular diseases.
• Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
• Patients with severe infections.
• History of immunodeficiency.
• History of autoimmune diseases.
• Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy.
• Active infection.
• Pregnant or nursing women.
• Known history of serious allergic reactions to the investigational product or its main ingredients.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Medical Unversity Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300181, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Zhenqun Lu

CONTACT

+86-0518-81220121; zhenqun.lu@hengrui.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: August 14, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (2)