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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
A homogeneous patient population will receive DT-9081 at up to 3 dose levels.
Institut Jules Bordet
Anderlecht, Belgium
Université Catholique de Louvain
Leuven, Belgium
Institut Curie
Paris, France
Institut Claudius Regaud
Toulouse, France
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
Number of participants with dose-limiting toxicities (DLTs).
Time frame: Cycle 1 (28 days)
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