Clinical trial NCT05982080: A Study to Investigate FP002 in Subjects With Advanced Malignancies
Official title: A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Guangdong Fapon Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form (ICF) and was able to comply with the protocol.
2. Male or female subjects ≥ 18 years of age on the day of ICF signing.
3. A life expectancy of \> 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
6. Subjects with histologically or cytological confirmed malignancy diagnosis.
7. 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.
8. Documented with at least 1 measurable lesion as assessed by RECIST 1.1.
9. Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.

Exclusion Criteria:

1. Subjects who have received other anti-CD47 or anti- SIRPα agents.
2. Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
3. Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
4. Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
5. 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.
6. Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
7. 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.
8. Cardiovascular dysfunction or clinically significant cardiac disease.
9. Active infection with hepatitis C.
10. Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
11. Known hypersensitivity to either the drug substances or inactive ingredient of FP002.
12. Known human immunodeficiency virus (HIV) positive.
13. 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.
14. Known inherited or acquired bleeding disorders.
15. Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
16. Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle 1.
17. 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.
18. Presence of active brain metastases

Primary outcomes:
measure: Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
timeFrame: During the first 4 week treatment cycle
measure: Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
timeFrame: up to 24 months
measure: Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
timeFrame: up to 24 months
measure: Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
timeFrame: up to 24 months
measure: Severity (as graded by CTCAE v5.0) of adverse events assessed
timeFrame: up to 24 months
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of FP002
timeFrame: up to 24 months
measure: Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002
timeFrame: up to 24 months
measure: Area under the curve extrapolated to infinity (AUC0-inf)of FP002
timeFrame: up to 24 months
measure: Time to reach maximum plasma concentration (Tmax) of FP002
timeFrame: up to 24 months
measure: Terminal elimination half-life (t1/2) of FP002
timeFrame: up to 24 months
measure: Apparent volume of distribution (Vd) of FP002
timeFrame: up to 24 months
measure: Clearance rate (CLz)
timeFrame: up to 24 months
measure: Terminal elimination rate constant (λz)
timeFrame: up to 24 months
measure: Mean retention time (MRT)
timeFrame: up to 24 months
measure: Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)
timeFrame: up to 24 months
measure: Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)
timeFrame: up to 24 months
measure: Average steady state concentration (Cav)
timeFrame: up to 24 months
measure: Steady-state clearance rate (CLss)
timeFrame: up to 24 months
measure: Steady-state volume of distribution (Vss)
timeFrame: up to 24 months
measure: Accumulation index (Rac)
timeFrame: up to 24 months
measure: Degree of fluctuation (DF)
timeFrame: up to 24 months
measure: Duration of response (DoR) based on RECIST V1.1
timeFrame: Up to 24 months
measure: Disease control rate (DCR) based on RECIST V1.1
timeFrame: Up to 24 months
measure: Overall response rate (ORR) based on RECIST V1.1
timeFrame: Up to 24 months
measure: Progression free survival (PFS) based on RECIST V1.1
timeFrame: Up to 24 months
measure: Anti-drug antibody
timeFrame: Up to 24 months
measure: Neutralizing antibody
timeFrame: Up to 24 months
measure: Receptor of occupancy in RBC/CD3+ T cell
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Jinan
country: China
facility: Shangdong Cancer Hospital & Institute
state: Shangdong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shangdong
Study officials:
affiliation: Shangdong Cancer Hospital & Institute
name: Yuping Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shangdong Cancer Hospital & Institute
name: Linlin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: