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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