Actively Recruiting
Phase I/II Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of FH-006 in adults with advanced malignant solid tumors. The study aims to find the highest dose patients can tolerate, determine the recommended dose for future trials, and gather early data on how well the treatment works. Participants receive FH-006 through intravenous injection either once every two weeks over a 28-day treatment period, or once every three weeks over a 21-day treatment period. The study includes dose escalation phases to identify maximum tolerated or administered doses and a dose expansion phase to further evaluate the recommended dose. Throughout the study, participants undergo monitoring for dose-limiting toxicities and adverse events for up to 30 days after their last dose. Researchers assess serious side effects, immune reactions to the drug, and treatment efficacy over an average of two years. The total duration and detailed assessments ensure thorough evaluation of FH-006's impact and safety.
CONDITIONS
Brief 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
- Diagnosed with recurrent or metastatic solid tumors confirmed by tissue or cell analysis
- Experienced disease progression after standard treatment or lacking suitable standard treatment options
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function
- Voluntary participation with signed informed consent
You will not qualify if you...
- Other cancers within the past 5 years
- Active brain metastases without surgery or radiation
- Uncontrolled fluid buildup in body spaces
- Anti-tumor treatment within 4 weeks prior to first dose
- Severe infection within 4 weeks before starting medication
- Active or history of autoimmune disease
- History of immune deficiency
- Serious heart or brain blood vessel diseases
- Significant lung disease history
- Unresolved toxicity from prior cancer treatments above grade 1
- Recent major surgery on key organs within 4 weeks
- Use of live attenuated vaccines within 28 days before first drug dose
- Other serious physical, mental, or lab abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 or 28 days per treatment cycle
Participants receive FH-006 by intravenous injection either once every two weeks or once every three weeks, with treatment periods of 28 days or 21 days respectively.
1 visit every 2 or 3 weeks depending on treatment arm
Duration - 30 days after last dose for safety monitoring; immunogenic monitoring up to 2 years
Participants are monitored for adverse events and immunogenic response for up to 30 days after the last dose, with immunogenic indicators tracked for an average of 2 years.
Visits as scheduled for safety and immunogenicity assessments
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaoxue Pi
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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