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

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

Gastrointestinal Stromal Tumor

Completed

1/2

Start Date 10/06/2017

Age of Trial (yrs) 6.5

Gleevec-resistant

HDAC inhibitor

Unblock cell death genes

Specifically GIST plus other cancers

EDO-S101-1002

Mundipharma-EDO GmbH

David Browning 615-975-7776 David.browning@edoncology.com Ahmed M. Faisal 781-349-7429 Ahmed.faisal@cromsource.com

Intravenous

Brief 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 tumors.

Detailed Description:

The study consists of 2 phases:

Phase 1: Dose Escalation until MAD
Phase 2: Evaluation of Toxicity and Response Rate in Selected Solid Tumor Cohorts

The study is designed as an open label, Phase 1/2 trial of single agent EDOS101. The Phase 1 portion of the study is designed to define the MTD for two (2) administration schedules by evaluating toxicities during dose escalation until MAD. The Phase 2 portion of the study is designed to evaluate ORR and CBR at four (4) or six (6) months depending on the type of solid tumor.


Phase 2
Cohort 2: Patient Population: Relapsed/Refractory Soft Tissue Sarcoma or Non-Kit GIST

Histologically confirmed diagnosis of advanced, unresectable, or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy excluding:

chondrosarcoma, neuroblastoma, osteosarcoma, embryonal rhabdomyosarcoma, or Kaposi sarcoma.
Must have received at least one prior line chemotherapy regimen and no other standard therapy with proven clinical benefit is available.
The disease should be progressing/relapsed during or after the previous treatment. At least 3 weeks should have elapsed since prior chemotherapy or 5 half-lives, whichever is shorter, as long as the patient recovered from any related toxicities to ≤ Grade 1.
Presence of measurable disease as defined by RECIST version 1.1

For GIST-patients: must have received at least two lines of tyrosine kinase inhibitors or do not respond to or for which tyrosine kinase inhibitor therapy is not suitable.