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
- Conditions
- Locally Advanced or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT06293651
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy DA-4505 Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers Combination with Pembrolizumab DA-4505 + Pembrolizumab Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers
- Primary Outcome Measures
Name Time Method Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria Cycle 1(21 days) in dose escalation The recommended Phase 2 dose(RP2D) will be the optimal biological dose (OBD) based on consideration of safety and tolerability information along with all available pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data.
PK parameters for DA-4505 (half-life (t1/2)) Day 1 and 2 of first 2 cycles (every 21 days) Determine DA-4505 half-life (t1/2).
PK parameters for DA-4505 (Area Under the Curve (AUC)) Day 1 and 2 of first 2 cycles (every 21 days) Determine DA-4505 AUC
Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) approximately 12 months To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab
PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) Day 1 and 2 of first 2 cycles (every 21 days) Determine DA-4505 Cmax
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of