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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FH-006 Group

FH-006 for injection monotherapy should be conducted.

Group Type EXPERIMENTAL

FH-006 for Injection

Intervention Type DRUG

FH-006 for injection.

Interventions

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FH-006 for Injection

FH-006 for injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No