Trials / Recruiting
RecruitingNCT06735144
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-12-23
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2024-12-16
- Last updated
- 2025-12-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06735144. Inclusion in this directory is not an endorsement.