A Study to Investigate FP002 in Subjects With Advanced Malignancies

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.

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