A Study of AP505 Injection in Patients With Advanced Malignant Solid Tumors

NCT06723964 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AP505-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Dose-Escalation : DLT Assessment

  Number of Participants With Dose Limiting Toxicity (DLT)

  From Day1 to Day15 after first dose of AP505

• AE Assessment

  All AEs and SAEs will be collected, regardless of the relationship to the IP.

  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).

• 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 Outcomes (6)

• To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors

  From C1D1 until 7 days after treatment discontinuation/ termination.

• To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors

  From first dose until 7 days after treatment discontinuation/ termination.

• To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors

  From first dose until 7 days after treatment discontinuation/ termination.

• To evaluate the pharmacokinetic (PK) profile of AP505 in patients with advanced solid tumors

  From first dose until 7 days after treatment discontinuation/ termination

• 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).

Study Arms (10)

AP505 0.035 mg/kg

EXPERIMENTAL

AP505 0.035 mg/kg Open Label

Drug: AP505

AP505 0.12 mg/kg

EXPERIMENTAL

AP505 0.12 mg/kg Open Label

Drug: AP505

AP505 0.4 mg/kg

EXPERIMENTAL

AP505 0.4 mg/kg Open Label

Drug: AP505

AP505 1.2 mg/kg

EXPERIMENTAL

AP505 1.2 mg/kg Open Label

Drug: AP505

AP505 4.0 mg/kg

EXPERIMENTAL

AP505 4.0 mg/kg Open Label

Drug: AP505

AP505 8.0 mg/kg

EXPERIMENTAL

AP505 8.0 mg/kg Open Label

Drug: AP505

AP505 11.0 mg/kg

EXPERIMENTAL

AP505 11.0 mg/kg Open Label

Drug: AP505

AP505 15.0 mg/kg

EXPERIMENTAL

AP505 15.0 mg/kg Open Label

Drug: AP505

AP505 20.0 mg/kg

EXPERIMENTAL

AP505 20.0 mg/kg Open Label

Drug: AP505

AP505 25.0 mg/kg

EXPERIMENTAL

AP505 25.0 mg/kg Open Label

Drug: AP505

Interventions

AP505 DRUG

AP505 is a Anti-PD-L1 and Anti-VEGF Antibody Fusion Protein.

AP505 0.035 mg/kg; AP505 0.12 mg/kg; AP505 0.4 mg/kg; AP505 1.2 mg/kg; AP505 11.0 mg/kg; AP505 15.0 mg/kg; AP505 20.0 mg/kg; AP505 25.0 mg/kg; AP505 4.0 mg/kg; AP505 8.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study and provide a signed and dated informed consent form (ICF).
• Male or female aged ≥ 18 years old (inclusive) at the time of signing the ICF.
• 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.
• Willing to comply with the visits, study treatment, laboratory examinations and other study-related procedures and requirements specified in the study protocol.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
• Expected survival time of more than 3 months.
• Have at least one measurable lesion per RECIST version 1.1.
• 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.
• 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.

You may not qualify if:

• Have received immune checkpoint inhibitors (ICIs) such as anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, or VEGF inhibitor such as bevacizumab, ramucirumab, apatinib, or regorafenib within 28 days prior to the first dose of the study drug.
• Known hypersensitivity to the study drug and any of its components; or known history of previous severe allergic reactions to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies.
• Female patient who is pregnant or breastfeeding.
• Received major surgery within 4 weeks prior to the first dose of the study drug or requiring major elective surgery during the study period.
• The adverse reactions caused by previous anti-tumor therapy have not been recovered to ≤ grade 1 per NCI CTCAE v5.0 (except for alopecia).
• Subjects with untreated or symptomatic brain metastases, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastases (Exception: Treated and stable symptoms, stable imaging for at least 4 weeks prior to first dose, with no evidence of cerebral edema, and no need for glucocorticoid therapy).
• Patients with pleural effusion, pericardial effusion or ascites that have shown clinical symptoms or requiring repeated drainage.
• Imaging during the screening period showed that the tumor surrounded important blood vessels or the presence of obvious tumor necrosis and cavitation, and the Investigator judged that entering the study may cause bleeding risk.
• Known history of human immunodeficiency virus (HIV) infection (positive for HIV 1/2 antibody test) or diseases related to acquired immunodeficiency syndrome (AIDS).
• Patients with hepatitis B infection undergoing treatment or requiring treatment (defined as hepatitis B surface antigen (HBsAg) positive, and HBV DNA \>1000 copies/mL (200IU/mL) or above the lower limit of the detection, whichever is higher); or patients with hepatitis C antibody (HCV-Ab) positive and HCVRNA quantification \> the upper limit of normal of the testing unit; or patients with known active syphilis infection.
• Patients with uncontrolled bacterial, viral, fungal infections, or other pathogen infections (such as mycoplasma, parasites, etc.) that need systemic treatment within 4 weeks prior to the first dose of the study drug.
• Known history of serious cardiovascular disease, including but not limited to:
• Ventricular arrhythmia requiring clinical intervention.
• Acute coronary syndrome (myocardial infarction and angina pectoris) within 6 months prior to the first dose of the study drug.
• Congestive heart failure (New York Heart Association (NYHA) class ≥ II) or left ventricular ejection fraction (LVEF) \< 50%;

Sponsors & Collaborators

• AP Biosciences Inc.: lead

Study Sites (1)

AP Biosciences, Inc.

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 9, 2024
• Study Start: March 30, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)