Actively Recruiting
Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-12-05
200
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years inclusive
- Histologically or cytologically confirmed recurrent or metastatic solid tumors
- Disease progression after standard treatment or no suitable standard treatment plan
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- At least one target lesion measurable by RECIST v1.1 criteria
- Good organ function
- Voluntary participation with signed informed consent
You will not qualify if you...
- Other malignancies within the past 5 years
- Active central nervous system metastasis without prior surgery or radiotherapy
- Uncontrollable third space effusion
- Anti-tumor treatment within 4 weeks before first dose
- Severe infection within 4 weeks before first medication
- Any active autoimmune disease or history of autoimmune disease
- History of immune deficiency
- Serious cardiovascular or cerebrovascular diseases
- Clinically significant lung disease
- Toxicity from previous anti-tumor treatment not recovered to grade I or lower
- Surgery on important organs within 4 weeks prior to first medication
- Use of attenuated live vaccine within 28 days prior to first investigational drug use
- Other serious physical or mental diseases or laboratory abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaoxue Pi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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