A Study to Investigate FP002 in Subjects With Advanced Malignancies

A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: FP002 Injection

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 Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Arron Wang; Phone Number: +86 13926091581; Email: clinitrial.register@fapon.com
• Study Contact Backup: Name: Vincent Huo; Phone Number: +86 13825280524; Email: clinitrial.register@fapon.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Wang Sheng; Email: shengwang81@126.com
      • Principal Investigator: Wang Sheng, M.M.
  • Shangdong
    • Jinan, Shangdong, China
      • Recruiting
      • Shangdong Cancer Hospital & Institute
      • Contact: Yuping Sun, MD; Phone Number: +86-531-67627156; Email: 13370582181@163.com
      • Principal Investigator: Yuping Kong, MD
      • Principal Investigator: Linlin Wang, MD
    • Linyi, Shangdong, China, 276000
      • Not yet recruiting
      • LinYi Cancer Hospital
      • Principal Investigator: Zhen Wang
      • Contact: Zhen Wang; Email: LYSZLYYNSK@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	Incidence, onset time and titer	Up to 24 months
Neutralizing antibody	Incidence, onset time and titer	Up to 24 months
Receptor of occupancy in RBC/CD3+ T cell		Up to 24 months

Collaborators and Investigators

• Sponsor: Guangdong Fapon Biopharma Inc.
• Investigators: Principal Investigator: Yuping Sun, MD, Shangdong Cancer Hospital & Institute; Principal Investigator: Linlin Wang, MD, Shangdong Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FP002-CT1001-CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No