A Study to Investigate FP002 in Subjects With Advanced Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FP002 Injection Dose escalation: FP002 |
Drug: FP002 Injection
Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.
|
Outcome Measures
Primary Outcome Measures
- 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 of special interest (AESIs) [up to 24 months]
- Severity (as graded by CTCAE v5.0) of adverse events assessed [up to 24 months]
Secondary Outcome Measures
- Maximum plasma concentration (Cmax) of FP002 [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]
- Area under the curve extrapolated to infinity (AUC0-inf)of FP002 [up to 24 months]
- Time to reach maximum plasma concentration (Tmax) of FP002 [up to 24 months]
- Terminal elimination half-life (t1/2) of FP002 [up to 24 months]
- Apparent volume of distribution (Vd) of FP002 [up to 24 months]
- Clearance rate (CLz) [up to 24 months]
- Terminal elimination rate constant (λz) [up to 24 months]
- Mean retention time (MRT) [up to 24 months]
- Maximum plasma concentration during the dosing interval at steady state (Cmax,ss) [up to 24 months]
- Minimum plasma concentration during the dosing interval at steady state (Cmin,ss) [up to 24 months]
- Average steady state concentration (Cav) [up to 24 months]
- Steady-state clearance rate (CLss) [up to 24 months]
- Steady-state volume of distribution (Vss) [up to 24 months]
- Accumulation index (Rac) [up to 24 months]
- Degree of fluctuation (DF) [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]
- Overall response rate (ORR) based on RECIST V1.1 [Up to 24 months]
- Progression free survival (PFS) based on RECIST V1.1 [Up to 24 months]
- Anti-drug antibody [Up to 24 months]
Incidence, onset time and titer
- Neutralizing antibody [Up to 24 months]
Incidence, onset time and titer
- Receptor of occupancy in RBC/CD3+ T cell [Up to 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent form (ICF) and was able to comply with the protocol.
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Male or female subjects ≥ 18 years of age on the day of ICF signing.
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A life expectancy of > 3 months.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
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Subjects with histologically or cytological confirmed malignancy diagnosis.
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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.
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Documented with at least 1 measurable lesion as assessed by RECIST 1.1.
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Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.
Exclusion Criteria:
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Subjects who have received other anti-CD47 or anti- SIRPα agents.
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Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
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Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
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Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
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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.
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Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
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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.
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Cardiovascular dysfunction or clinically significant cardiac disease.
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Active infection with hepatitis C.
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Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
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Known hypersensitivity to either the drug substances or inactive ingredient of FP002.
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Known human immunodeficiency virus (HIV) positive.
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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.
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Known inherited or acquired bleeding disorders.
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Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
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Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle 1.
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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.
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Presence of active brain metastases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China | 361003 |
| 2 | Shangdong Cancer Hospital & Institute | Jinan | Shangdong | China | |
| 3 | Linyi Cancer Hospital | Linyi | Shangdong | China | 276000 |
Sponsors and Collaborators
- Guangdong Fapon Biopharma Inc.
Investigators
- Principal Investigator: Yuping Sun, MD, Shangdong Cancer Hospital & Institute
- Principal Investigator: Linlin Wang, MD, Shangdong Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FP002-CT1001-CN