Clinical trial NCT06735144: Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Malignant Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: DLT: 21or28 days after the first administration of each subject
timeFrame: 21or28 days after the first administration of each subject
measure: AE: from Day1 to 30 days after last dose
timeFrame: from Day1 to 30 days after last dose
measure: Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose
timeFrame: from Day1 to 30 days after last dose
measure: MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage
timeFrame: 21 or 28 days after the first dose of medication for each subject on dose escalation stage
measure: RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase
timeFrame: Obtain two treatment evaluation data for the last subject during the dose expansion phase
Secondary outcomes:
measure: Immunogenic indicators: anti-FH-006 antibody (ADA)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: