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

NCT06293651 | Recruiting Phase 1

• 1 other identifier: DA4505_AMST_I/IIa
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief 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 Metastatic Solid Tumors.

Conditions

Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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.

  Cycle 1(21 days) in dose escalation

• PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))

  Determine DA-4505 Cmax

  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

  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).

  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

  approximately 12 months

Study Arms (2)

Monotherapy

EXPERIMENTAL

Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers

Drug: DA-4505

Combination with Pembrolizumab

EXPERIMENTAL

Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers

Drug: DA-4505 + Pembrolizumab

Interventions

DA-4505 DRUG

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

Monotherapy

DA-4505 + Pembrolizumab DRUG

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

Combination with Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (2)

Asan Medical Center

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Jayun Jang

CONTACT

+82-2-920-8306; janycan@donga.co.kr

Hye-yeong Han

CONTACT

hyhan@donga.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 5, 2024
• Study Start: April 18, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

KR (2)