Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059

Phase 1

Completed

• Conditions: Desmoid Tumor
• Interventions: Drug: Tegavivint

• Registration Number: NCT03459469
• Lead Sponsor: Iterion Therapeutics

Brief Summary

Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.

Detailed Description

This study is a phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive. This study will utilize single patient cohorts for the first two dose levels in order to minimize sub-optimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD or RP2D determined by pharmacokinetics or biologically relevant activity. Once MTD or RP2D is determined, that dose level cohort will expand to 14 patients enrolled to collect additional safety PK and PD data. If at least 1 patient has clinical benefit, the dose expansion phase will be expanded by a further 11 patients (25 total in at RP2D). The total duration of study for each subject will be dependent upon the safety, tolerability and efficacy of BC2059

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-09
• Study Start: 2018-07-15
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational drug	Tegavivint	An open-label, non-randomized study to evaluate safety of Tegavivint administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability	12 Months	Adverse events, Serious adverse events and Dose limiting toxicities

Secondary Outcome Measures

Name	Time	Method
1. To determine the durability of response (DOR) to BC2059 after the achievement of best response	12 Months	Assessing CR and PR

Trial Locations

Locations (7)

The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States