Actively Recruiting
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
Led by Dong-A ST Co., Ltd. · Updated on 2025-02-12
125
Participants Needed
2
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 and older
- Able to give signed informed consent
- Diagnosed with locally advanced or metastatic solid tumors
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female patients must not be pregnant or breastfeeding
- Male patients must agree to remain abstinent or use condoms with female partners of childbearing potential, or have had a bilateral vasectomy
- Have measurable disease by RECIST version 1.1 criteria
You will not qualify if you...
- Unable to take oral medications or have gastrointestinal problems that may affect absorption
- Currently enrolled or previously participated in another clinical trial
- Have unresolved adverse reactions (except hair loss) from prior cancer treatment
- Use of cancer-directed therapies including CAR T-cell therapy
- Had autologous transplantation within 60 days
- Prior allogeneic transplantation
- Major surgery within 30 days or unresolved complications from surgery
- History of or active cardiovascular disease
- Significant disorders affecting respiratory, liver, kidney, gastrointestinal, endocrine, blood, or nervous systems
- History of other malignancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
2
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jayun Jang
CONTACT
H
Hye-yeong Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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