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A Study to Investigate FP002 in Subjects With Advanced Malignancies

Primary Purpose

Advanced Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
FP002 Injection
Sponsored by
Guangdong Fapon Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Xiamen University
  • Shangdong Cancer Hospital & InstituteRecruiting
  • Linyi Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FP002 Injection

Arm Description

Dose escalation: FP002

Outcomes

Primary Outcome Measures

Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
Severity (as graded by CTCAE v5.0) of adverse events assessed

Secondary Outcome Measures

Maximum plasma concentration (Cmax) of FP002
Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002
Area under the curve extrapolated to infinity (AUC0-inf)of FP002
Time to reach maximum plasma concentration (Tmax) of FP002
Terminal elimination half-life (t1/2) of FP002
Apparent volume of distribution (Vd) of FP002
Clearance rate (CLz)
Terminal elimination rate constant (λz)
Mean retention time (MRT)
Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)
Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)
Average steady state concentration (Cav)
Steady-state clearance rate (CLss)
Steady-state volume of distribution (Vss)
Accumulation index (Rac)
Degree of fluctuation (DF)
Duration of response (DoR) based on RECIST V1.1
Disease control rate (DCR) based on RECIST V1.1
Overall response rate (ORR) based on RECIST V1.1
Progression free survival (PFS) based on RECIST V1.1
Anti-drug antibody
Incidence, onset time and titer
Neutralizing antibody
Incidence, onset time and titer
Receptor of occupancy in RBC/CD3+ T cell

Full Information

First Posted
July 7, 2023
Last Updated
August 23, 2023
Sponsor
Guangdong Fapon Biopharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05982080
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Fapon Biopharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FP002 Injection
Arm Type
Experimental
Arm Description
Dose escalation: FP002
Intervention Type
Drug
Intervention Name(s)
FP002 Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
Time Frame
During the first 4 week treatment cycle
Title
Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
Time Frame
up to 24 months
Title
Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
Time Frame
up to 24 months
Title
Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
Time Frame
up to 24 months
Title
Severity (as graded by CTCAE v5.0) of adverse events assessed
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of FP002
Time Frame
up to 24 months
Title
Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002
Time Frame
up to 24 months
Title
Area under the curve extrapolated to infinity (AUC0-inf)of FP002
Time Frame
up to 24 months
Title
Time to reach maximum plasma concentration (Tmax) of FP002
Time Frame
up to 24 months
Title
Terminal elimination half-life (t1/2) of FP002
Time Frame
up to 24 months
Title
Apparent volume of distribution (Vd) of FP002
Time Frame
up to 24 months
Title
Clearance rate (CLz)
Time Frame
up to 24 months
Title
Terminal elimination rate constant (λz)
Time Frame
up to 24 months
Title
Mean retention time (MRT)
Time Frame
up to 24 months
Title
Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)
Time Frame
up to 24 months
Title
Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)
Time Frame
up to 24 months
Title
Average steady state concentration (Cav)
Time Frame
up to 24 months
Title
Steady-state clearance rate (CLss)
Time Frame
up to 24 months
Title
Steady-state volume of distribution (Vss)
Time Frame
up to 24 months
Title
Accumulation index (Rac)
Time Frame
up to 24 months
Title
Degree of fluctuation (DF)
Time Frame
up to 24 months
Title
Duration of response (DoR) based on RECIST V1.1
Time Frame
Up to 24 months
Title
Disease control rate (DCR) based on RECIST V1.1
Time Frame
Up to 24 months
Title
Overall response rate (ORR) based on RECIST V1.1
Time Frame
Up to 24 months
Title
Progression free survival (PFS) based on RECIST V1.1
Time Frame
Up to 24 months
Title
Anti-drug antibody
Description
Incidence, onset time and titer
Time Frame
Up to 24 months
Title
Neutralizing antibody
Description
Incidence, onset time and titer
Time Frame
Up to 24 months
Title
Receptor of occupancy in RBC/CD3+ T cell
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arron Wang
Phone
+86 13926091581
Email
clinitrial.register@fapon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Huo
Phone
+86 13825280524
Email
clinitrial.register@fapon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuping Sun, MD
Organizational Affiliation
Shangdong Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linlin Wang, MD
Organizational Affiliation
Shangdong Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Sheng
Email
shengwang81@126.com
First Name & Middle Initial & Last Name & Degree
Wang Sheng, M.M.
Facility Name
Shangdong Cancer Hospital & Institute
City
Jinan
State/Province
Shangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuping Sun, MD
Phone
+86-531-67627156
Email
13370582181@163.com
First Name & Middle Initial & Last Name & Degree
Yuping Kong, MD
First Name & Middle Initial & Last Name & Degree
Linlin Wang, MD
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shangdong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang
Email
LYSZLYYNSK@163.com
First Name & Middle Initial & Last Name & Degree
Zhen Wang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Investigate FP002 in Subjects With Advanced Malignancies

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