Investigating DA-4505 and Pembrolizumab for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Asan Medical Center
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jayun Jang
• Email: janycan@donga.co.kr
• Phone: +82-2-920-8306

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.