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Recruiting NCT06293651

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

Phase I / Phase II Interventional Locally Advanced or Metastatic Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-4505, DA-4505 + Pembrolizumab.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug DA-4505
    Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
  • Drug DA-4505 + Pembrolizumab
    Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab

Primary outcome measures

  • Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria [Time frame: Cycle 1(21 days) in dose escalation]
  • PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) [Time frame: Day 1 and 2 of first 2 cycles (every 21 days)]
  • PK parameters for DA-4505 (Area Under the Curve (AUC)) [Time frame: Day 1 and 2 of first 2 cycles (every 21 days)]
  • PK parameters for DA-4505 (half-life (t1/2)) [Time frame: 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) [Time frame: approximately 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Asan Medical Center — Seoul
  • Severance Hospital — Seoul

Identifiers

NCT: NCT06293651 · DA4505_AMST_I/IIa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗