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Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

an Open-Label, Phase 1/2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

NCT06293651•Dong-A ST Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 and older.
•2. Capable of giving signed informed consent.
•3. Diagnosed with particular disease characteristics.
•4. Expected survival ≥ 3 months.
•5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
•6. A female patient is eligible to participate if she is not pregnant or breastfeeding.
•7. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.
•8. Have measurable disease by revised RECIST v1.1 criteria.

Exclusion Criteria

•1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
•2. Current enrollment or past participation in another clinical trial.
•3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.
•4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.
•5. Autologous transplantation within 60 days.
•6. Prior allogeneic transplantation.
•7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.
•8. History of or currently active cardiovascular disease.
•9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
•10. History of other malignancy.

Locations (2)

Asan Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Key Dates

Start Date

April 18, 2024

Primary Completion Date

January 1, 2026

Completion Date

October 1, 2029

Last Updated

February 12, 2025

Enrollment

125

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Solid Tumors

Interventions

DA-4505

DRUG

DA-4505 + Pembrolizumab

DRUG

Contacts

Jayun Jang

CONTACT

+82-2-920-8306 janycan@donga.co.kr

Hye-yeong Han

CONTACT

hyhan@donga.co.kr

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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: February 12, 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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Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

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