NCT06990698 A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors
| NCT ID | NCT06990698 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhuhai Fapon Biopharma Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2028-05 |
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 108 participants in total. It began in 2025-06-12 with a primary completion date of 2028-05.
⚠ 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
The goal of the phase 1 study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of FP008 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Signed written ICF and be able to comply with the protocol. 2. Male and female subjects ≥18 years of age. 3. Life expectancy of \>3 months. 4. Laboratory values for sufficient organ function at screening. 5. Toxicity from prior antitumor treatment has resolved to ≤Grade 1 as defined by NCI CTCAE v5.0. 6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of FP008. 7. Male or women of childbearing potential, if sexually active, must agree to use contraception considered adequate and appropriate by the investigator during the period of study drug administration and for at least 5 months after the last dose of FP008. 8. ECOG performance status of 0 to 1. 9. Histologically or cytologically confirmed malignancy diagnosis and at least one measurable documented advanced/unresectable or metastatic solid tumor as assessed by RECIST v1.1. 10. Documented progressive disease, refractory/resistance/intolerant to standard therapy (documented the reason(s) why they are intolerant to standard therapy by the investigator), or there is no standard therapy. Exclusion Criteria: 1. Subjects who have received other IL-10 agents. 2. A history of other malignancies other than basal cell carcinoma of skin, squamous cell carcinoma of skin, non-muscle invasive bladder cancer, thyroid papillary carcinoma or carcinoma in situ of the cervix that have been cured for 2 years after effective treatment. 3. Received live vaccine within 30 days prior to the first dose of FP008. 4. Not completely recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of FP008. 5. Known hypersensitivity to either the drug substances or inactive ingredient of FP008. 6. Subjects with diagnosis of immunodeficiency, organ transplant requiring immunosuppressive therapy, or allogeneic bone marrow or hematopoietic stem cell transplant. 7. Daily requirement for corticosteroids within 2 weeks prior to first dose of FP008. 8. Any other medical disorder, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that the investigator considers unsuitable for participation in the study. 9. Cardiovascular dysfunction or clinically significant cardiac disease.
Contact & Investigator
Aung Naing, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06990698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. 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 NCT06990698 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 NCT06990698 currently recruiting?
Yes, NCT06990698 is actively recruiting participants. Contact the research team at clinitrial.register@fapon.com for enrollment information.
Where is the NCT06990698 trial being conducted?
This trial is being conducted at Guangzhou, China, Wuhan, China, Nanchang, China, Taiyuan, China and 2 additional locations.
Who is sponsoring the NCT06990698 clinical trial?
NCT06990698 is sponsored by Zhuhai Fapon Biopharma Co., Ltd.. The principal investigator is Aung Naing, MD at M.D. Anderson Cancer Center. The trial plans to enroll 108 participants.