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Trial Title: 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

NCT ID: NCT06293651

Condition: Locally Advanced or Metastatic Solid Tumors

Conditions: Official terms:
Neoplasms
Pembrolizumab

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DA-4505
Description: Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
Arm group label: Monotherapy

Intervention type: Drug
Intervention name: DA-4505 + Pembrolizumab
Description: Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab
Arm group label: Combination with Pembrolizumab

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: March 2024

Completion date: April 2030

Lead sponsor:
Agency: Dong-A ST Co., Ltd.
Agency class: Industry

Source: Dong-A ST Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06293651

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