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Trial Title:
A Study to Investigate FP002 in Subjects With Advanced Malignancies
NCT ID:
NCT05982080
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FP002 Injection
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.
Arm group label:
FP002 Injection
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wang Sheng
Email:
shengwang81@126.com
Investigator:
Last name:
Wang Sheng, M.M.
Email:
Principal Investigator
Facility:
Name:
Shangdong Cancer Hospital & Institute
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun, MD
Phone:
+86-531-67627156
Email:
13370582181@163.com
Investigator:
Last name:
Yuping Kong, MD
Email:
Principal Investigator
Investigator:
Last name:
Linlin Wang, MD
Email:
Principal Investigator
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhen Wang
Email:
LYSZLYYNSK@163.com
Investigator:
Last name:
Zhen Wang
Email:
Principal Investigator
Start date:
August 2, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Guangdong Fapon Biopharma Inc.
Agency class:
Industry
Source:
Guangdong Fapon Biopharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982080
