Advanced Solid Tumors
Conditions
Brief summary
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of AP505 injection in patients with advanced solid tumors. The study will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for AP505.
Interventions
DRUGAP505
AP505 is a Anti-PD-L1 and Anti-VEGF Antibody Fusion Protein.
Sponsors
AP Biosciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Voluntarily participate in this study and provide a signed and dated informed consent form (ICF). 2. Male or female aged ≥ 18 years old (inclusive) at the time of signing the ICF. 3. Patients with histologically and/or cytologically confirmed advanced solid tumor, who have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds, or refused to standard treatment (late or last line). Note: for subjects who are eligible based on intolerance to standard therapy or considered ineligible for standard therapies in the opinion of the investigator, the basis of this determination should be captured in the case report forms. 4. Willing to comply with the visits, study treatment, laboratory examinations and other study-related procedures and requirements specified in the study protocol. 5. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. 6. Expected survival time of more than 3 months. 7. Have at least one measurable lesion per RECIST version 1.1. 8. Adequate organ and bone marrow function: * Hematology (no blood transfusion, no G-CSF, no medication correction within 2 weeks prior to screening): Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (Hb) ≥ 90 g/L. * Liver function: total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0×ULN, aspartate aminotransferase (AST) ≤ 3.0×ULN; for patients with liver metastases: ALT ≤ 5.0×ULN, AST ≤ 5.0×ULN; * Renal function: creatinine clearance (CrCL) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); * Coagulation function: prothrombin time (PT) ≤ 1.5×ULN or international normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN. 9. For female patients: * Females of childbearing potential who are not breastfeeding must agree to use highly effective contraceptives from the time of signing the ICF and use such contraceptives during the study and for at least 6 months after the last dose of the study drug; The blood pregnancy test result (human chorionic gonadotropin, hCG) must be negative within 3 days prior to enrollment. * Women who are infertile (i.e., physiologically incapable of becoming pregnant), including those surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or postmenopausal (non-treatment-induced amenorrhea) for ≥ 12 months prior to screening. 10. For male patients with fertile female partners, they must agree to use high-efficiency contraception from the time of signing the ICF and to use such contraception during the study and for at least 6 months after the last dose of the study drug.
Exclusion criteria
In order to participate in this study, all subjects must meet NONE of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Escalation : DLT Assessment | From Day1 to Day15 after first dose of AP505 | Number of Participants With Dose Limiting Toxicity (DLT) |
| AE Assessment | From screening to follow-up period which includes safety follow-up (30/60/90 days after last dose) and survival follow-up (every 3 months until subject loss to follow-up, death, withdrawal of consent, or study termination, whichever occurs first). | All AEs and SAEs will be collected, regardless of the relationship to the IP. |
| Determine the maximum tolerated dose (MTD) | From first dose of AP505 until 28 days after the last dose of AP505 | — |
| Determine the recommended phase II dose (RP2D) | From first dose of AP505 until 28 days after the last dose of AP505 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors | From C1D1 until 7 days after treatment discontinuation/ termination. | Peak Plasma Concentration (Cmax) Analysis |
| To characterize the immunogenicity profile of AP505 in patients with advanced solid tumors | From C1D1 (Cycle 1 is 15 days ; Cycle 2 onwards: each cycle is 28 days), until safety follow up (up to 90 days after the last dose). | Immunogenicity indicators: the level of anti-drug antibody (ADA). |
Countries
Taiwan
Outcome results
None listed