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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FH-006 for patients with advanced malignant solid tumors, which are a type of cancer that forms in solid organs like the lungs, breast, or colon. The main goals of the study are to find out how safe FH-006 is, how well it is tolerated by patients, and to gather information on how the body processes the drug. Researchers will also determine the highest dose that can be given safely and gather early information on how effective the treatment may be.

To participate in this trial, you need to be a woman aged 18 to 75 with a confirmed diagnosis of recurrent or metastatic solid tumors that have worsened after standard treatments, or for which no standard treatment options are available. You should have a good level of organ function and an expected survival of at least three months. Participants will receive the FH-006 treatment and will be monitored closely for any side effects. It's important to know that certain health conditions and recent treatments may prevent someone from joining the study, so potential participants should discuss their medical history with their doctor to see if they qualify.

Gender

ALL

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