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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase 1/2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

NCT05473156•AP Biosciences Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent by the participants or the participant's legally authorized representative prior to screening.
•2. 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.
•3. 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.
•4. 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:
•1. Absolute neutrophil count ≥ 1.5 × 109 /L.
•2. Platelet count ≥ 100 × 109 /L.
•3. Hemoglobin ≥ 9 g/dL.
•4. Alanine aminotransferase and AST ≤ 2.5 × ULN or \< 5 × ULN if hepatic metastases present.
•5. Serum total bilirubin ≤ 1.5 × ULN (or \< 3 × ULN for participants with Gilbert's syndrome).
+21 more criteria

Exclusion Criteria

•1. 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).
•2. Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).
•3. 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.
•4. Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
•5. 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.
•6. 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.
•7. Participants who received any organ transplantation including allogeneic stem cell transplantation.
•8. Participants with significant acute or chronic infections including, among others:
+15 more criteria

Locations (1)

AP Biosciences Inc.

Taipei, Taiwan

Key Dates

Start Date

July 24, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

March 26, 2025

Enrollment

168

ESTIMATED participants

Conditions

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

Interventions

AP203

DRUG

AP203

DRUG

Contacts

Ya Shen

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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