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 preclinical 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
Secondary Outcome:
  • 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)
The study consists of 2 phases:
  • 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society