TRIAL DETAIL

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

Drug:
Trial Name:
Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1/2
Start Date 10/06/2017
Age of Trial (yrs) 4
Treatment Phase:
Gleevec-resistant
Drug Category:
HDAC inhibitor
Strategy:
Unblock cell death genes
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
EDO-S101-1002
Sponsor:
Mundipharma-EDO GmbH
Patient Contact:
David Browning 615-975-7776 David.browning@edoncology.com Ahmed M. Faisal 781-349-7429 Ahmed.faisal@cromsource.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Intravenous
Trial Notes:
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

Trial Links

Trial Results

Drug Information

NCI Drug Dictionary - bendamustine-vorinostst fusion molecule EDO-S101
 
MundiPharma-EDO presentation on EDO-S101
 

Trial Sites

Name
Address
City
State
Zip
Country
8700 Beverly Blvd.
Los Angeles
CA
90048
USA
Palo Alto
CA
94304
USA
675 North St. Clair
Chicago
IL
60611
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
550 First Avenue
New York
NY
10016
USA
Dallas
TX
75201
USA
Montreal
QC
H4A 3J1
Canada