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

NCT ID: NCT06735144

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2027-12-31

Brief Summary

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.

Conditions

Malignant Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Queue A

Group Type: EXPERIMENTAL

FH-006

Intervention Type: DRUG

Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days

Queue B

Group Type: EXPERIMENTAL

FH-006

Intervention Type: DRUG

administered once every 3 weeks (Q3W), with a treatment period of 21 days

Interventions

FH-006

Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days

Intervention Type: DRUG

FH-006

administered once every 3 weeks (Q3W), with a treatment period of 21 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Women aged 18 to 75 (inclusive)

2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.

3. ECOG score is 0 or 1

4. An expected survival of ≥3 months

5. At least one target lesion according to RECIST v1.1 criteria

6. Has a good level of organ function

7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria

1. Have other malignancies within the past 5 years

2. Active central nervous system metastasis without surgery or radiotherapy

3. Presence with uncontrollable third space effusion

4. Have undergone other anti-tumor treatment within 4 weeks before the first dose

5. Has severe infection within 4 weeks before the first medication

6. Any active autoimmune disease or a history of autoimmune disease

7. A history of immune deficiency

8. Has serious cardiovascular and cerebrovascular diseases

9. Clinically significant history of lung disease

10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I

11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication

12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug

13. Presence of other serious physical or mental diseases or laboratory abnormalities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoxue Pi

Role: CONTACT

Xiaoxue.pi@hengrui.com

0518-82342973

Other Identifiers

FH-006-101

Identifier Type: -

Identifier Source: org_study_id