Actively Recruiting
A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors
Led by Zhuhai Fapon Biopharma Co., Ltd. · Updated on 2025-10-02
108
Participants Needed
3
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with the study protocol
- Male or female aged 18 years or older
- Life expectancy greater than 3 months
- Adequate organ function based on screening laboratory tests
- Resolution of prior antitumor treatment toxicities to Grade 1 or less
- Negative pregnancy test within 7 days before starting FP008 for women of childbearing potential
- Agreement to use effective contraception during treatment and for 5 months after last dose if sexually active
- ECOG performance status of 0 to 1
- Confirmed diagnosis of advanced, unresectable, or metastatic solid tumor with at least one measurable lesion
- Disease progression or intolerance to standard therapy, or no available standard therapy
You will not qualify if you...
- Previous treatment with other IL-10 agents
- History of other cancers except certain skin cancers, non-muscle invasive bladder cancer, thyroid papillary carcinoma, or carcinoma in situ of the cervix cured for at least 2 years
- Receipt of live vaccines within 30 days before first FP008 dose
- Not fully recovered from major surgery or serious injury within 14 days prior to first dose
- Known allergy to FP008 or its ingredients
- Diagnosis of immunodeficiency, organ transplant requiring immunosuppressants, or bone marrow/stem cell transplant
- Daily corticosteroid use within 2 weeks before first FP008 dose
- Any medical or psychiatric condition deemed unsuitable by the investigator
- Cardiovascular or significant heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430014
Actively Recruiting
2
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
A
Arron Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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