Investigating DA-4505 and Pembrolizumab for Advanced Solid Tumors

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

This study is testing a new treatment called DA-4505, both alone and with Pembrolizumab, to see if it helps adults with advanced solid tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dong-A ST Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor, Pembrolizumab
• Locations: 2 sites (Seoul and 1 other locations)
• Trial ID: NCT06293651 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, Phase 1/2a study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DA-4505, both as a standalone treatment and in combination with Pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. The study will involve dose-escalation and dose-expansion phases to determine the optimal dosing and effectiveness of the treatments. Participants will be monitored for adverse effects and treatment responses throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic solid tumors and an expected survival of at least three months.

Not a fit: Patients who have unresolved adverse reactions from previous cancer therapies or are currently enrolled in another clinical trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is being explored for the first time.

Eligibility criteria

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.

Where this trial is running

Seoul and 1 other locations

• Asan Medical Center — Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Jayun Jang

Conditions Locally Advanced or Metastatic Solid Tumors