Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. (EDO-S101 Trial)
Palo Alto (17 mi)Overseen byShivaani Kummar, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Mundipharma-EDO GmbH
No Placebo Group
Trial Summary
What is the purpose of this trial?Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.
Eligibility Criteria
Treatment Details
13Treatment groups
Experimental Treatment
Group I: Tinostamustine (EDO-S101) - Sub study 2 (SS2)Experimental Treatment1 Intervention
Group II: Tinostamustine (EDO-S101) - Sub study 1 (SS1)Experimental Treatment1 Intervention
Group III: Tinostamustine (EDO-S101) - Phase 2 Relapsed/refractory Triple Negative breast Cancer (TNBC) cohortExperimental Treatment1 Intervention
Group IV: Tinostamustine (EDO-S101) - Phase 2 Relapsed/refractory Soft Tissue Sarcoma (STS) cohortExperimental Treatment1 Intervention
Group V: Tinostamustine (EDO-S101) - Phase 2 Relapsed/refractory Small Cell Lung Cancer (SCLC) cohortExperimental Treatment1 Intervention
Group VI: Tinostamustine (EDO-S101) - Phase 2 Relapsed/refractory Ovarian Cancer (OC) cohortExperimental Treatment1 Intervention
Group VII: Tinostamustine (EDO-S101) - Phase 2 Relapsed/refractory Endometrial Cancer (EC) cohortExperimental Treatment1 Intervention
Group VIII: Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 min) cohort 5Experimental Treatment1 Intervention
Group IX: Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 min) cohort 2Experimental Treatment1 Intervention
Group X: Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 min) cohort 4Experimental Treatment1 Intervention
Group XI: Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 min) cohort 1Experimental Treatment1 Intervention
Group XII: Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 min) cohort 6Experimental Treatment1 Intervention
Group XIII: Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 min) cohort 3Experimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Northwestern UniversityChicago, IL
Stanford University Medical CenterPalo Alto, CA
Georgetown UniversityWashington, United States
Mary Crowley Cancer ResearchDallas, TX
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Who is running the clinical trial?
Mundipharma-EDO GmbHLead Sponsor
Mundipharma Research LimitedLead Sponsor