Clinical trial NCT06293651: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced or Metastatic Solid Tumors
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria
timeFrame: Cycle 1(21 days) in dose escalation
measure: PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))
timeFrame: Day 1 and 2 of first 2 cycles (every 21 days)
measure: PK parameters for DA-4505 (Area Under the Curve (AUC))
timeFrame: Day 1 and 2 of first 2 cycles (every 21 days)
measure: PK parameters for DA-4505 (half-life (t1/2))
timeFrame: Day 1 and 2 of first 2 cycles (every 21 days)
measure: Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1)
timeFrame: approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: