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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDong-A ST Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 and older.

Capable of giving signed informed consent.

Diagnosed with particular disease characteristics.

Expected survival ≥ 3 months.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • DA-4505
  • DA-4505 + Pembrolizumab

Treatment groups

125 Participants
are divided into 2 treatment groups

Sponsors and collaborators