NCT05582850

DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours

A Phase 1, Multicentre, Open-label, Dose-escalation and Expansion Study to Determine a Recommended Phase 2 Dose (RP2D) of DT-9081 in Participants With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Domain Therapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended phase 2 dose (RP2D) of DT-9081, followed by an expansion study of DT-9081 in participants with advanced, recurrent or metastatic solid tumours

Detailed description

This first-in-human Phase 1, multicentre, open label study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumours who failed standard of care therapies. This Phase 1 study consists of 2 parts. The first part is a dose-escalation using a modified 3+3 design with up to 8 dose escalation cohorts at increasing levels. The dose-escalation part aims at determining the recommended phase 2 dose. The second part is an expansion to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081. Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	DT-9081 - dose escalation	Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
DRUG	DT-9081 - expansion	A homogeneous patient population will receive DT-9081 at up to 3 dose levels.

Timeline

• Start date: 2022-11-24
• Primary completion: 2025-04-08
• Completion: 2025-07-28
• First posted: 2022-10-17
• Last updated: 2025-08-28

Locations

4 sites across 2 countries: Belgium, France