A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors

NCT06990698 | Recruiting Phase 1 FDA Drug

• 1 other identifier: FP008-CT1001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (7)

• Dose-limiting toxicities (DLTs)

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of TEAEs leading to discontinuation of study treatment

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of TRAEs leading to discontinuation of study treatment

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of SAEs leading to discontinuation of study treatment

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of irAEs leading to discontinuation of study treatment

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of AESIs leading to discontinuation of study treatment

  Up to 2 years

• Severity (as graded by NCI CTCAE v5.0) of AEs leading to discontinuation of study treatment

  Up to 2 years

Secondary Outcomes (21)

• Maximum plasma concentration (Cmax) of FP008

  Up to 2 years

• Time to reach maximum plasma concentration (Tmax) of FP008

  Up to 2 years

• Area under the curve from time zero to the last measurable time point (AUC0-tlast) of FP008

  Up to 2 years

• Area under the curve extrapolated to infinity (AUC0-inf)of FP008

  Up to 2 years

• Apparent volume of distribution (V) of FP008

  Up to 2 years

Study Arms (1)

FP008 for injection

EXPERIMENTAL

Drug: FP008 for injection

Interventions

FP008 for injection DRUG

FP008 should be administered intravenous weekly. Six FP008 dose levels are planned to evaluated.

FP008 for injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written ICF and be able to comply with the protocol.
• Male and female subjects ≥18 years of age.
• Life expectancy of \>3 months.
• Laboratory values for sufficient organ function at screening.
• Toxicity from prior antitumor treatment has resolved to ≤Grade 1 as defined by NCI CTCAE v5.0.
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of FP008.
• 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.
• ECOG performance status of 0 to 1.
• Histologically or cytologically confirmed malignancy diagnosis and at least one measurable documented advanced/unresectable or metastatic solid tumor as assessed by RECIST v1.1.
• 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.

You may not qualify if:

• Subjects who have received other IL-10 agents.
• 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.
• Received live vaccine within 30 days prior to the first dose of FP008.
• Not completely recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of FP008.
• Known hypersensitivity to either the drug substances or inactive ingredient of FP008.
• Subjects with diagnosis of immunodeficiency, organ transplant requiring immunosuppressive therapy, or allogeneic bone marrow or hematopoietic stem cell transplant.
• Daily requirement for corticosteroids within 2 weeks prior to first dose of FP008.
• 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.
• Cardiovascular dysfunction or clinically significant cardiac disease.

Sponsors & Collaborators

• Zhuhai Fapon Biopharma Co., Ltd.: lead

Study Sites (3)

Hubei Cancer Hospital

Wuhan, Hubei, 430014, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arron Wang

CONTACT

86-13926091581; clinitrial.register@fapon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-07

Locations

CN (3)