First-in-human Study of M4076 in Advanced Solid Tumours (DDRiver Solid Tumours 410)

Titre officiel

A First-in-human, Phase I, Open-label Study of the ATM Inhibitor M4076 in Participants With Advanced Solid Tumours (DDRiver Solid Tumours 410)

Sommaire:

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumours in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) is declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.

Description de l'essai

Primary Outcome:

• Part 1A: Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
• Part 1A: Occurrence of Adverse Events (AEs) and Treatment-Related AEs
• Part 1A: Number of Participants With Clinical Significant Changes in Vital Signs, Laboratory Parameters, and 12-Lead Electrocardiogram (ECG) Findings
• Part 1B: Occurrence of Adverse Events (AEs) and Treatment-Related AEs
• Part 1B: Number of Participants With Clinical Significant Changes in Vital Signs, Laboratory Parameters, and 12-Lead Electrocardiogram (ECG) Findings

• Part 1A and Part 1B: Objective Response According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigators
• Part 1A and Part 1B: Duration of Response According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigators
• Part 1A and Part 1B: Progression Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigators
• Part 1A and Part 1B: Overall Survival (OS)
• Part 1A and 1B: Area Under Plasma Concentration-Time Curve (AUC) From Time Zero (= Dosing Time) to the Last Sampling Time (tlast) of M4076
• Part 1A and Part 1B: Area Under Plasma Concentration (AUC) From Time Zero (Dosing Time) Extrapolated to Infinity (AUC0-inf) of M4076
• Part 1A and Part 1B: Maximum Observed Plasma Concentration (Cmax) of M4076
• Part 1A and Part 1B: Absolute and Relative Changes From Baseline in Ataxia-Telangiectasia Mutated (ATM) Pathway Readouts Assessed by Flow Cytometry and Immunohistochemistry

Voir cet essai sur ClinicalTrials.gov