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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Locally Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DA-4505

Drug

Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D

DA-4505 + Pembrolizumab

Drug

Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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).

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hye-yeong Han

CONTACT

[email protected]

Jayun Jang

CONTACT

[email protected]

+82-2-920-8306

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Mar 5, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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