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

Locally Advanced or Metastatic Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293651
• Other study ID #: DA4505_AMST_I/IIa
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2024
• Est. completion date: April 2030

Study information

• Verified date: February 2024
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Metastatic Solid Tumors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: April 2030
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 and older.

2. Capable of giving signed informed consent.

3. Diagnosed with particular disease characteristics.

4. Expected survival = 3 months.

5. Eastern Cooperative Oncology Group (ECOG) performance status = 1.

6. A female patient is eligible to participate if she is not pregnant or breastfeeding.

7. 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.

8. Have measurable disease by revised RECIST v1.1 criteria.

Exclusion Criteria:

1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.

2. Current enrollment or past participation in another clinical trial.

3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.

4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.

5. Autologous transplantation within 60 days.

6. Prior allogeneic transplantation.

7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.

8. History of or currently active cardiovascular disease.

9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.

10. History of other malignancy.

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))	Determine DA-4505 Cmax	Day 1 and 2 of first 2 cycles (every 21 days)
Primary	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)
Primary	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)
Primary	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