FP008 treatment for adults with advanced solid tumors

A Phase 1 First-In-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP008 in Subjects With Advanced Solid Tumors

This phase 1 trial will test FP008 to see if it is safe and shows signs of antitumor activity in adults with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhuhai Fapon Biopharma Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT06990698 on ClinicalTrials.gov

What this trial studies

This first-in-human, multicenter, open-label phase 1 program gives FP008 by injection to adults with advanced, measurable solid tumors who have progressed on prior therapies. Part 1 uses dose-escalation to define tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and a recommended dose/schedule for expansion. Part 2 enrolls patients into dose-expansion cohorts to further characterize safety, PK/PD, immunogenicity, and preliminary efficacy at the selected dose(s). Investigators will use standard toxicity grading and RECIST v1.1 to monitor safety and tumor responses.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed unresectable or metastatic solid tumors, measurable disease by RECIST v1.1, ECOG performance status 0–1, life expectancy >3 months, adequate organ function, and disease progression after prior therapy are appropriate candidates.

Not a fit: Patients with ECOG >1, life expectancy ≤3 months, unresolved ≥Grade 2 toxicities from prior therapy, significant organ dysfunction, or who cannot comply with contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, FP008 could become a new treatment option that is tolerable and helps control or shrink advanced solid tumors.

How similar studies have performed: This is a first-in-human trial so FP008 has not been tested in people before, and while some first-in-human oncology agents have led to later approvals, many investigational agents do not.

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.

Where this trial is running

Wuhan, Hubei and 2 other locations

• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Aung Naing, MD — M.D. Anderson Cancer Center
• Study coordinator: Arron Wang

Conditions Advanced Solid Tumors