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

Phase 1

Recruiting

• Conditions: Malignant Solid Tumor
• Interventions: Drug: FH-006

• Registration Number: NCT06735144
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Study Start: 2024-12-23
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Queue B	FH-006	-
Queue A	FH-006	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China