A Study to Investigate FP002 in Subjects With Advanced Malignancies
Phase 1
Recruiting
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: FP002 Injection
- Registration Number
- NCT05982080
- Lead Sponsor
- Guangdong Fapon Biopharma Inc.
- Brief Summary
The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.
- Detailed Description
This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor. The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile, immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid tumors.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Signed informed consent form (ICF) and was able to comply with the protocol.
- Male or female subjects ≥ 18 years of age on the day of ICF signing.
- A life expectancy of > 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
- Subjects with histologically or cytological confirmed malignancy diagnosis.
- Documented advanced solid tumors, defined as patients have no standard treatment or who have failed/are intolerant to standard treatment according to the investigator's judgment.
- Documented with at least 1 measurable lesion as assessed by RECIST 1.1.
- Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.
Exclusion Criteria
- Subjects who have received other anti-CD47 or anti- SIRPα agents.
- Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
- Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
- Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
- Subjects who have received chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose (within 6 weeks before the first dose of mitomycin or nitrosoureas) or received immunotherapy, radical radiotherapy or major surgery within 4 weeks or palliative radiotherapy within 2 weeks.
- Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
- A positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first dose of study treatment.
- Cardiovascular dysfunction or clinically significant cardiac disease.
- Active infection with hepatitis C.
- Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
- Known hypersensitivity to either the drug substances or inactive ingredient of FP002.
- Known human immunodeficiency virus (HIV) positive.
- A history of other malignancies other than effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or effectively resected carcinoma in situ of the cervix.
- Known inherited or acquired bleeding disorders.
- Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
- Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle 1.
- Women who are lactating or pregnant as confirmed by pregnancy test within 7 days before the first dose of study treatment. Unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of study treatment.
- Presence of active brain metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FP002 Injection FP002 Injection Dose escalation: FP002
- Primary Outcome Measures
Name Time Method Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs) up to 24 months Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT) During the first 4 week treatment cycle Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs) up to 24 months Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs) up to 24 months Severity (as graded by CTCAE v5.0) of adverse events assessed up to 24 months
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of FP002 up to 24 months Clearance rate (CLz) up to 24 months Minimum plasma concentration during the dosing interval at steady state (Cmin,ss) up to 24 months Progression free survival (PFS) based on RECIST V1.1 Up to 24 months Terminal elimination half-life (t1/2) of FP002 up to 24 months Mean retention time (MRT) up to 24 months Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002 up to 24 months Apparent volume of distribution (Vd) of FP002 up to 24 months Terminal elimination rate constant (λz) up to 24 months Area under the curve extrapolated to infinity (AUC0-inf)of FP002 up to 24 months Accumulation index (Rac) up to 24 months Neutralizing antibody Up to 24 months Incidence, onset time and titer
Average steady state concentration (Cav) up to 24 months Overall response rate (ORR) based on RECIST V1.1 Up to 24 months Steady-state clearance rate (CLss) up to 24 months Steady-state volume of distribution (Vss) up to 24 months Degree of fluctuation (DF) up to 24 months Time to reach maximum plasma concentration (Tmax) of FP002 up to 24 months Maximum plasma concentration during the dosing interval at steady state (Cmax,ss) up to 24 months Duration of response (DoR) based on RECIST V1.1 Up to 24 months Disease control rate (DCR) based on RECIST V1.1 Up to 24 months Anti-drug antibody Up to 24 months Incidence, onset time and titer
Receptor of occupancy in RBC/CD3+ T cell Up to 24 months
Trial Locations
- Locations (3)
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Shangdong Cancer Hospital & Institute
🇨🇳Jinan, Shangdong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shangdong, China