Status:
RECRUITING
A Study to Investigate FP002 in Subjects With Advanced Malignancies
Lead Sponsor:
Guangdong Fapon Biopharma Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05982080
Start Date
August 2 2023
End Date
July 1 2026
Last Update
August 25 2023
Active Locations (3)
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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