Locally Advanced or Metastatic Solid Tumors
Conditions
Brief 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.
Interventions
DRUGDA-4505
Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D
DRUGDA-4505 + Pembrolizumab
Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria | Cycle 1(21 days) in dose escalation | The recommended Phase 2 dose(RP2D) will be the optimal biological dose (OBD) based on consideration of safety and tolerability information along with all available pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data. |
| PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) | Day 1 and 2 of first 2 cycles (every 21 days) | Determine DA-4505 Cmax |
| PK parameters for DA-4505 (Area Under the Curve (AUC)) | Day 1 and 2 of first 2 cycles (every 21 days) | Determine DA-4505 AUC |
| PK parameters for DA-4505 (half-life (t1/2)) | Day 1 and 2 of first 2 cycles (every 21 days) | Determine DA-4505 half-life (t1/2). |
| Response per revised Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) | approximately 12 months | To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab |
Countries
South Korea
Contacts
Primary ContactJayun Jang
Backup ContactHye-yeong Han
Outcome results
None listed