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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
FP008 for injection
DrugFP008 should be administered intravenous weekly. Six FP008 dose levels are planned to evaluated.
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: FP008 for injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLTs)
Time frame
Up to 2 years2
Severity (as graded by NCI CTCAE v5.0) of TEAEs leading to discontinuation of study treatment
Time frame
Up to 2 years3
Severity (as graded by NCI CTCAE v5.0) of TRAEs leading to discontinuation of study treatment
Time frame
Up to 2 years4
Severity (as graded by NCI CTCAE v5.0) of SAEs leading to discontinuation of study treatment
Time frame
Up to 2 yearsSecondary outcomes
1
Maximum plasma concentration (Cmax) of FP008
Time frame
Up to 2 years2
Time to reach maximum plasma concentration (Tmax) of FP008
Time frame
Up to 2 years3
Area under the curve from time zero to the last measurable time point (AUC0-tlast) of FP008
Time frame
Up to 2 years4
Area under the curve extrapolated to infinity (AUC0-inf)of FP008
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov