Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT06293651
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
A Phase 1/2 study testing DA-4505 and DA-4505 + Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors, run by Dong-A ST Co., Ltd. at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- DA-4505 and DA-4505 + Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Apr 2024to Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hye-yeong Han contact
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Severance Hospital
Seoul
About this study
Official title: 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
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.
- Being tested
- DA-4505, DA-4505 + Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-4505Drug
Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
DA-4505 + PembrolizumabDrug
Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers Receives: Drug: DA-4505 |
| Combination with Pembrolizumab | Experimental | Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers Receives: Drug: DA-4505 + Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
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.
Measured: Cycle 1(21 days) in dose escalation
PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))
Determine DA-4505 Cmax
Measured: Day 1 and 2 of first 2 cycles (every 21 days)
PK parameters for DA-4505 (Area Under the Curve (AUC))
Determine DA-4505 AUC
Measured: Day 1 and 2 of first 2 cycles (every 21 days)
PK parameters for DA-4505 (half-life (t1/2))
Determine DA-4505 half-life (t1/2).
Measured: Day 1 and 2 of first 2 cycles (every 21 days)
Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1)
To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab
Measured: approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start18 Apr 2024
- Primary completionJan 2026 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293651
- Sponsor's protocol ID
- DA4505_AMST_I/IIa
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No