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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06293651
- Acronym / sponsor ID
- DA4505_AMST_I/IIa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: DA-4505Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers |
| Combination with Pembrolizumab | Experimental | Drug: DA-4505 + PembrolizumabPhase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-4505Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D | Drug | Monotherapy |
| DA-4505 + PembrolizumabPhase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab | Drug | Combination with Pembrolizumab |
Primary outcome
Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
Time frame: 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 (Peak Plasma Concentration (Cmax))
Time frame: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 Cmax
PK parameters for DA-4505 (Area Under the Curve (AUC))
Time frame: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 AUC
PK parameters for DA-4505 (half-life (t1/2))
Time frame: Day 1 and 2 of first 2 cycles (every 21 days)
Determine DA-4505 half-life (t1/2).
Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1)
Time frame: approximately 12 months
To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hye-yeong Han contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayun Jang (+82-2-920-8306, janycan@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria (time frame: Cycle 1(21 days) in dose escalation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.