Actively Recruiting
Open-Label Phase 1/2a Study of DA-4505 Alone and With Pembrolizumab in Adults 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
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and effects of DA-4505 alone and combined with Pembrolizumab in adults with locally advanced or metastatic solid tumors. This open-label, phase 1/2a trial is the first time DA-4505 is being tested in humans, aiming to understand its impact and potential benefits as a new treatment option. The study includes several parts: Phase 1a focuses on increasing doses to find safe levels, Phase 1b expands treatment at those doses, and Phase 2a examines biological markers and proof of concept for the treatment's effects. Participants receive DA-4505 either by itself or together with a fixed dose of Pembrolizumab, with dosing schedules and combinations adjusted during the different phases. Participants will be closely monitored throughout the study with regular safety checks, blood tests to track DA-4505 levels, and tumor assessments using RECIST criteria over about 12 months. Researchers will track adverse events, drug concentrations at specific times, and tumor responses to evaluate how well the treatment works and its safety. The trial includes follow-up visits to observe outcomes and side effects during and after treatment.
CONDITIONS
Brief 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 years or older
- Able to provide signed informed consent
- Diagnosed with locally advanced or metastatic solid tumors with measurable disease per RECIST v1.1
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female participants must not be pregnant or breastfeeding
- Male participants must agree to abstain or use condoms with women of childbearing potential or have had a bilateral vasectomy
You will not qualify if you...
- Unable to take oral medications or have gastrointestinal issues affecting absorption
- Currently enrolled or previously participated in another clinical trial
- Unresolved side effects from prior cancer treatment except hair loss
- Use of cancer-directed therapies including CAR T-cell therapy
- Autologous transplant within 60 days
- Previous allogeneic transplant
- Major surgery within 30 days or unresolved complications from surgery
- History or active cardiovascular disease
- Significant respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders
- History of other cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Cycle 1 (21 days) in dose escalation
Participants start dose escalation and pharmacokinetic assessments of DA-4505 alone or in combination with pembrolizumab.
Visits on Day 1 and Day 2 of the first 2 cycles (every 21 days)
Duration - Up to approximately 12 months
Participants receive DA-4505 alone or with pembrolizumab at recommended doses during dose expansion and pharmacodynamic biomarker evaluation.
Regular visits for treatment and response evaluations
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
H
Hye-yeong Han
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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