Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

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