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

Launched by DONG-A ST CO., LTD. · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called DA-4505, both on its own and together with another medication called Pembrolizumab, for adults with locally advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original site. The goal of the study is to understand how safe the treatment is, how well it works, and how the body processes the medication. The trial is currently looking for participants aged 18 and older who can give informed consent and are expected to live for at least three more months.

To be eligible, participants should have specific types of tumors that can be measured and should be in good enough health to participate. They should not have any major health issues that could affect their ability to take the medication or have recently undergone certain cancer treatments or surgeries. If you or someone you know might be interested in joining this trial, you can expect close monitoring by medical professionals and will be contributing to important research that could help improve cancer treatments in the future.

Gender

ALL

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.