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July 23, 2024

PHASE I DOSE ESCALATION STUDY OF 3-WEEKLY INTRAVENOUS DPPG2-TSL-DOX COMBINED WITH REGIONAL HYPERTHERMIA IN LOCALLY ADVANCED OR METASTATIC SOFT TISSUE SARCOMA

This phase 1 study aims to explore a new therapeutic approach for advanced soft tissue sarcoma (STS) by investigating the safety, tolerability, and maximum tolerable dose (MTD) of DPPG2-TSL-DOX combined with regional hyperthermia (RHT) in patients who have been pre-treated with doxorubicin (DOX). DPPG2-TSL-DOX is a novel formulation of DOX encapsulated in DPPG2-containing temperature sensitive liposomes. Regional hyperthermia (RHT) with a tumor target temperature of ≥106.7 to ≤111.2 degrees Fahrenheit triggers a localized release of DOX into the tumor.

https://clinicaltrials.gov/study/NCT05858710

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July 23, 2024

TAPUR STUDY: PARTICIPANTS RECEIVE ABEMACICLIB – DOSAGE, FREQUENCY AND DURATION PER LABEL; ACCEPTABLE GENOMIC MATCHES INCLUDE CDK4 AMPLIFICATION

This phase 2 study is a nonrandomized, open label study enrolling patients of all tumor types, including soft tissue sarcomas. One of the study arms investigates the study drug abemaciclib (Verzenio), an oral targeted therapy, for patients who are no longer benefitting from standard treatment, and whose tumor has a CDK4 amplification. The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.

There are over 250 clinical sites across 28 states in the United States. For more information on the TAPUR Study, visit the TAPUR website at www.TAPUR.org. If you would like to learn more, the study team recently held a virtual live Grand Rounds which was recorded. The May 2023 TAPUR Grand Rounds recording is available for viewing and can be found under the “Study Results” page of the TAPUR website.

ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02693535
Sponsor website: www.TAPUR.org

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July 23, 2024

YH001 PLUS ENVAFOLIMAB WITH OR WITHOUT DOXORUBICIN IN PATIENTS WITH ADVANCED OR METASTATIC SARCOMA

This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT05448820?term=envafolimab&draw=3
Sponsor website:   www.traconpharma.com

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