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
Dong-A ST Co., Ltd.
125 participants
Apr 18, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Aged 18 and older.
- Capable of giving signed informed consent.
- Diagnosed with particular disease characteristics.
- Expected survival ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- A female patient is eligible to participate if she is not pregnant or breastfeeding.
- 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.
- Have measurable disease by revised RECIST v1.1 criteria.
Exclusion Criteria10
- Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
- Current enrollment or past participation in another clinical trial.
- Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.
- Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.
- Autologous transplantation within 60 days.
- Prior allogeneic transplantation.
- Major surgery within 30 days, or unresolved complications after a major or minor surgery.
- History of or currently active cardiovascular disease.
- Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- History of other malignancy.
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Interventions
Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06293651