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

A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Tumor
• Intervention / Treatment: Drug: FH-006; Drug: FH-006

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoxue Pi; Phone Number: 0518-82342973; Email: Xiaoxue.pi@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Principal Investigator: Li Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Queue A	Drug: FH-006; Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days; Drug: FH-006; administered once every 3 weeks (Q3W), with a treatment period of 21 days
Experimental: Queue B	Drug: FH-006; Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days; Drug: FH-006; administered once every 3 weeks (Q3W), with a treatment period of 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DLT: 21or28 days after the first administration of each subject	21or28 days after the first administration of each subject
AE: from Day1 to 30 days after last dose	from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose	from Day1 to 30 days after last dose
MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage	21 or 28 days after the first dose of medication for each subject on dose escalation stage
RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase	Obtain two treatment evaluation data for the last subject during the dose expansion phase

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenic indicators: anti-FH-006 antibody (ADA)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FH-006-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No