Malignant Solid Tumor
Conditions
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.
Interventions
DRUGFH-006
Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence and severity of serious adverse events (SAE): 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 |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenic indicators: anti-FH-006 antibody (ADA) | through study completion, an average of 2 years |
Countries
China
Contacts
Primary ContactXiaoxue Pi
Outcome results
None listed