Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Women aged 18 to 75 (inclusive)
- 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.
- ECOG score is 0 or 1
- An expected survival of ≥3 months
- At least one target lesion according to RECIST v1.1 criteria
- Has a good level of organ function
- Patients voluntarily joined the study and signed informed consent
Exclusion Criteria
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- Has severe infection within 4 weeks before the first medication
- Any active autoimmune disease or a history of autoimmune disease
- A history of immune deficiency
- Has serious cardiovascular and cerebrovascular diseases
- Clinically significant history of lung disease
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- Having undergone surgery on important organs within 4 weeks prior to the first use of medication
- Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
- 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 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 Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose from Day1 to 30 days after last dose
- Secondary Outcome Measures
Name Time Method Immunogenic indicators: anti-FH-006 antibody (ADA) through study completion, an average of 2 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular targets does FH-006 modulate in malignant solid tumors to enhance anti-tumor immunity?
How does FH-006's preliminary efficacy compare to standard-of-care immunotherapies in advanced solid tumors?
Which biomarkers predict response to FH-006 in patients with malignant solid tumors?
What are the most common adverse events associated with FH-006 and their management strategies in oncology?
What combination therapies involving FH-006 are being explored for malignant solid tumors and their mechanisms?
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center🇨🇳Guangzhou, Guangdong, ChinaLi ZhangPrincipal Investigator