A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhuhai Fapon Biopharma Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- FP008 for injection
Treatment groups
108 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov