Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DA-4505 | Drug | — | UNRESOLVED |
| DA-4505 + Pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy
- description
- Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers
- interventionNames
- Drug: DA-4505
- type
- EXPERIMENTAL
- label
- Combination with Pembrolizumab
- description
- Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers
- interventionNames
- Drug: DA-4505 + Pembrolizumab
Primary outcomes (5)
- measure
- Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available