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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

ConditionLocally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDong-A ST Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Aged 18 and older.

Capable of giving signed informed consent.

Diagnosed with particular disease characteristics.

Expected survival ≥ 3 months.

Disqualifiers

Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.

Current enrollment or past participation in another clinical trial.

Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.

Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DA-4505

    Drug

    Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D

  • DA-4505 + Pembrolizumab

    Drug

    Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: MonotherapyExperimental treatment 1 intervention
Group B: Combination with PembrolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria

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.

Time frame
Cycle 1(21 days) in dose escalation
2

PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))

Determine DA-4505 Cmax

Time frame
Day 1 and 2 of first 2 cycles (every 21 days)
3

PK parameters for DA-4505 (Area Under the Curve (AUC))

Determine DA-4505 AUC

Time frame
Day 1 and 2 of first 2 cycles (every 21 days)
4

PK parameters for DA-4505 (half-life (t1/2))

Determine DA-4505 half-life (t1/2).

Time frame
Day 1 and 2 of first 2 cycles (every 21 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dong-A ST Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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