A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

NCT05473156 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AP203-101
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.

Conditions

Locally Advanced or Metastatic Solid Tumors; Non Small Cell Lung Cancer (NSCLC); Head and Neck Squamous Cell Carcinoma (HNSCC); Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (3)

• Dose-Escalation: Number of Participants With Dose Limiting Toxicity (DLT)

  DLT is defined as toxicity (adverse event \[AE\] at least possibly related to AP203) occurring during the DLT evaluation period

  The initial 28 days and completion of the first 4 doses of treatment

• Both Dose-Escalation and Dose-Expansion: Number of Participants With Adverse Events (AEs) and Serious AEs

  Safety assessed using incidence, nature, and severity of AEs and SAEs

  At screening (≤ 28 days before the first dose of AP203), up to 90 days after the last dose

• Dose-Expansion: Overall response rate(ORR) (assessed by the Investigator according to RECIST version 1.1)

  ORR is defined as the proportion of participants with CR or PR

  At screening (≤ 28 days before the first dose of AP203, up to 90 days after the last dose

Study Arms (4)

Dose-Escalation

EXPERIMENTAL

Drug: AP203

Dose-Expansion (Non Small Cell Lung Cancer, NSCLC)

EXPERIMENTAL

Drug: AP203

Dose-Expansion (Head and Neck Squamous Cell Carcinoma, HNSCC)

EXPERIMENTAL

Drug: AP203

Dose-Expansion (Esophageal Squamous Cell Carcinoma, ESCC)

EXPERIMENTAL

Drug: AP203

Interventions

AP203 DRUG

Eight dose levels ranging from 0.00064 to 20 mg/kg will be evaluated to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) or the recommended phase 2 dose(s) (RP2D\[s\]). Participants will be administered by intravenous (IV) infusion, every week (Q1W \[± 1days\]) for the first 3 weeks (from the first to the fourth dose), then administered every 2 weeks (Q2W \[± 3 days\]) for all the following doses.

Dose-Escalation

Eligibility Criteria

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

You may qualify if:

• Written informed consent by the participants or the participant's legally authorized representative prior to screening.
• Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
• Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a previously irradiated area are not considered measurable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.
• Participants with adequate organ function defined by the following:
• Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening:
• Absolute neutrophil count ≥ 1.5 × 109 /L.
• Platelet count ≥ 100 × 109 /L.
• Hemoglobin ≥ 9 g/dL.
• Alanine aminotransferase and AST ≤ 2.5 × ULN or \< 5 × ULN if hepatic metastases present.
• Serum total bilirubin ≤ 1.5 × ULN (or \< 3 × ULN for participants with Gilbert's syndrome).
• Alkaline phosphatase ≤ 2.5 × ULN or \< 5 × ULN if bone metastases present.
• Prothrombin time ≤ 1.5 × ULN.
• International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for participants on a stable dose of anticoagulants.
• Estimated creatinine clearance \> 50 mL/min according to the Cockcroft Gault formula
• Participants with highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists.

You may not qualify if:

• Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before the start of study intervention (e.g., chemotherapy, radiotherapy \[with the exception of palliative bone directed radiotherapy\], immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin).
• Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
• Participants who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, \< Grade 2 sensory neuropathy.
• Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
• Participants with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
• Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
• a. Brain imaging at screening shows no evidence of interim progression, participant is clinically stable for at least 2 weeks and without evidence of new brain metastases.
• b. Measurable disease outside the CNS. c. No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP203; anticonvulsants at a stable dose are allowed.
• Participants who received any organ transplantation including allogeneic stem cell transplantation.
• Participants with significant acute or chronic infections including, among others:
• o Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Note: An HIV serology test (including antigen and/or antibodies) will be conducted at baseline for the participants with unknown HIV status and participants with positive HIV test will be excluded.
• o Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) \> 500 IU/mL (or \> 2500 copies/mL) at screening.
• Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \< 500 IU/mL or \< 2500 copies/mL) can be enrolled. Participants with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Participants receiving antivirals at screening should have been treated for \> 2 weeks before the first dose of AP203.
• o Participants with active hepatitis C. Note: Participants with a negative hepatitis C virus (HCV) antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will be performed only for participants testing positive for HCV antibody. Participants receiving antivirals at screening should have been treated for \> 2 weeks before the first dose of AP203.

Sponsors & Collaborators

• AP Biosciences Inc.: lead

Study Sites (1)

AP Biosciences Inc.

Taipei, 115011, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Ya Shen

CONTACT

+886-2-2653-2886#117; yashen@apbioinc.com

Study Design

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

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: July 24, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

TW (1)