NCT06735144 Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors
| NCT ID | NCT06735144 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Malignant Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2024-12-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06735144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Malignant Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06735144 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06735144 currently recruiting?
Yes, NCT06735144 is actively recruiting participants. Contact the research team at Xiaoxue.pi@hengrui.com for enrollment information.
Where is the NCT06735144 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06735144 clinical trial?
NCT06735144 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 200 participants.