Actively Recruiting
A Study to Investigate FP002 in Subjects With Advanced Malignancies
Led by Guangdong Fapon Biopharma Inc. · Updated on 2023-08-25
27
Participants Needed
3
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate FP002 in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow the study protocol
- Male or female aged 18 years or older
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ and bone marrow function confirmed within 7 days before first treatment
- Confirmed diagnosis of malignancy by tissue or cell analysis
- Advanced solid tumors with no standard treatment options or intolerance to standard treatments
- At least one measurable tumor lesion assessed by RECIST 1.1
- Side effects from prior anti-tumor treatments resolved to Grade 1 or less per NCI CTCAE v5.0
You will not qualify if you...
- Previous treatment with anti-CD47 or anti-SIRPα agents
- Prior organ or tissue transplant except hematopoietic stem cell transplantation
- Investigational therapy within 4 weeks before starting study drug
- Severe infection requiring hospitalization or IV antibiotics, antivirals, or antifungals within 14 days prior to enrollment
- Chemotherapy within 4 weeks or 5 half-lives before first dose (6 weeks for mitomycin or nitrosoureas), immunotherapy, radical radiotherapy or major surgery within 4 weeks, or palliative radiotherapy within 2 weeks
- Active autoimmune disease requiring systemic therapy within past 2 years
- Positive COVID-19 test within 30 days before first dose
- Cardiovascular dysfunction or significant heart disease
- Active hepatitis C infection
- Live vaccine within 30 days before first dose
- Known allergy to FP002 or its ingredients
- HIV positive status
- History of other malignancies except certain effectively treated skin or cervical cancers
- Known bleeding disorders
- Any other medical, family, social, or mental condition deemed unsuitable by investigator
- Daily corticosteroid use (≥10 mg/kg) within 2 weeks before first treatment
- Pregnant or breastfeeding women or unwilling to use contraception during and 7 months after treatment
- Presence of active brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
2
Shangdong Cancer Hospital & Institute
Jinan, Shangdong, China
Actively Recruiting
3
Linyi Cancer Hospital
Linyi, Shangdong, China, 276000
Not Yet Recruiting
Research Team
A
Arron Wang
CONTACT
V
Vincent Huo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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