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

NCT07136142 | 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 (3)

• 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.

• 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)

  Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  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.

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

Firstly, FH-006 for injection monotherapy should be conducted for some tumors. Then FH-006 in combination with other anti-cancer treatment would be conduction for the specific tumor, including SHR-1316 injection with or without Albumin-bound paclitaxel.

Drug: FH-006 for Injection; Drug: SHR-1316 Injection; Drug: Paclitaxel for Injection (Albumin-Bound)

Interventions

SHR-1316 Injection DRUG

SHR-1316 Injection.

FH-006 Group

Paclitaxel for Injection (Albumin-Bound) DRUG

Paclitaxel for Injection (Albumin-Bound).

FH-006 Group

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

RECRUITING

Tianjin Medical Unversity Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

MeSH Terms

Interventions

Injections; Paclitaxel

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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

Model Details: FH-006 for injection monotherapy, or in combination with other anti-cancer therapy.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (2)