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Alkylating agents

Tinostamustine (EDO-S101) for Soft Tissue Sarcoma

Phase 1 & 2
Waitlist Available
Led By Shivaani Kummar, MD
Research Sponsored by Mundipharma-EDO GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months from beginning phase 2
Awards & highlights

Study Summary

This trial is testing a new drug, Tinostamustine, which in pre-clinical studies has shown to improve access to DNA strands within cancer cells, break them, and block damage repair.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Small Cell Lung Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Endometrial Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months from beginning phase 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months from beginning phase 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) and SD that persists for at least 4 months in selected solid tumor cohorts
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
Secondary outcome measures
PK: Area Under the Curve [AUC]
PK: Elimination half-life [t½]
PK: Maximum Plasma Concentration [Cmax]
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tinostamustine (EDO-S101)Experimental Treatment1 Intervention
Phase 1: Schedule A: Tinostamustine (EDO-S101), IV, 60mg/m2 up to 100mg/m2 Day 1 and 15 of each 28 day cycle Phase 2: The RP2D and selected schedule will be further investigated in patients with specific types of solid tumors: relapsed/refractory SCLC, soft tissue sarcoma, triple negative breast cancer, ovarian cancer and endometrial cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tinostamustine
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Mundipharma-EDO GmbHLead Sponsor
4 Previous Clinical Trials
157 Total Patients Enrolled
Mundipharma Research LimitedLead Sponsor
37 Previous Clinical Trials
829,604 Total Patients Enrolled
Shivaani Kummar, MDPrincipal InvestigatorOregon Health and Science University
6 Previous Clinical Trials
197 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
2017. "Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03345485.
~9 spots leftby Apr 2025
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