First in Human Study of M1069 in Advanced Solid Tumours

Titre officiel

First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M1069 in Participants With Metastatic or Locally Advanced Unresectable Solid Tumours

Sommaire:

The main purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.

Description de l'essai

Primary Outcome:

• Safety Profile as Assessed by Incidence of Adverse Events (AEs), Treatment-Related AEs and Dose-Limiting Toxicities (DLTs)

• Pharmacodynamic Assessment by Phosphorylated cAMP Response Element-binding Protein (pCREB) Level in ex-vivo Stimulated Blood
• Change from Baseline in Tumour Microenvironment (TME) in Available Paired Tumour Biopsies at Cycle 2 Day 15
• Pharmacokinetic (PK) Plasma Concentrations of M1069
• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), as Assessed by Investigator
• Duration of Response (DoR)
• Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1), as Assessed by Investigator
• Change from Baseline in Corrected QT (QTc) Interval Over Time

Voir cet essai sur ClinicalTrials.gov