Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumours

Official Title

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of EDO-S101, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients With Advanced Solid Tumours

Summary:

Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule), that in pre-clinical studies has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumours.

Trial Description

Primary Outcome:

• Safety: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
• Objective Response Rate (ORR) and SD that persists for at least 4 months in selected solid tumour cohorts

• PK: Maximum Plasma Concentration [Cmax]
• PK: Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
• PK: Area Under the Curve [AUC]
• PK: Elimination half-life [t½]
• Response Rate: Progression Free Survival (PFS)
• Response Rate: Overall Survival (OS)

• Phase 1: Dose Escalation until MAD

• Phase 2: Evaluation of Toxicity and Response Rate in Selected Solid Tumour Cohorts The study is designed as an open label, Phase 1/2 trial of single agent EDO-S101. The Phase 1 portion of the study is designed to define the MTD by evaluating toxicities during dose escalation until MAD. The Phase 2 portion of the study is designed to evaluate ORR and SD that persists for at least 4 months of the RP2D.

View this trial on ClinicalTrials.gov