Leiomyosarcoma
AN OPEN-LABEL, SINGLE-ARM, MULTICOHORT, PHASE 2 STUDY TO ASSESS THE EFFICACY AND SAFETY OF TABELECLEUCEL IN SUBJECTS WITH EPSTEIN-BARR VIRUS-ASSOCIATED DISEASES
This is a multi-cohort, Phase 2, single arm, open label study of tabelecleucel (allogenic EBV-specific T-cell immunotherapy) in patients with EBV+ sarcoma, to include leiomyosarcoma (one of six cohorts). Patients can be newly diagnosed or failed a first-line therapy for EBV+ sarcoma. Newly diagnosed patients should be ineligible to receive standard first-line therapy. Primary objective is to evaluate the clinical benefit of tabelecleucel.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04554914
Sponsor website: www.atarabio.com
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Dedifferentiated Liposarcoma
BRIGHTLINE-1: A STUDY TO COMPARE BI 907828 WITH DOXORUBICIN IN PEOPLE WITH A TYPE OF CANCER CALLED DEDIFFERENTIATED LIPOSARCOMA
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.
The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.
During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects.
ClinicalTrials.gov:https://clinicaltrials.gov/ct2/show/NCT05218499
Sponsor website: https://brightline-1.researchstudytrial.com/
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| Secondary Peripheral Atypical Cartilaginous Tumor / Chondrosarcoma, Grade 1 | Angiosarcoma
STUDY OF LOXO-101 IN SUBJECTS WITH NTRK FUSION POSITIVE SOLID TUMORS
This phase 2 study will enroll patients of all tumor types, including sarcomas, who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the sarcoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions in these cancers. This study will measure how well and for how long LOXO-101 works. Patients with a sarcoma who would not be able to receive any other options for treatment can participate in this trial. If you are not sure if your cancer has one of these NTRK fusions, talk to your doctor about available options to have your tumor tissue tested.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02576431?term=NCT02576431&draw=2&rank=1
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Dedifferentiated Liposarcoma
SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma
SARC041, is for patients who are 18 and older and have recurrent and/or metastatic dedifferentiated liposarcoma. Patients will either receive abemaciclib or a placebo when they enroll, and they will not know which drug they are receiving at the time of enrollment. A patient who experiences progression of their cancer while receiving the placebo pill will be allowed to receive abemaciclib instead. There is no specific biomarker required for eligibility for this study.
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| Undifferentiated Pleomorphic Sarcoma
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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Synovial Sarcoma
PHASE I/IB STUDY OF NK EXPRESSING AN AFFINITY-ENHANCED T-CELL RECEPTOR (TCR) AGAINST THE NY-ESO-1
This is an open-label phase 1 study to determine how well NY-ESO-1 TCR/IL-15 NK is tolerated, its safety, and the dose range in patients with relapsed/refractory synovial sarcoma or myxoid/round cell liposarcoma, who have undergone at least one prior line of therapy involving doxorubicin and/or ifosfamide. NY-ESO-1 TCR/IL-15 NK is a cell therapy that uses natural killer cells from cord blood to mount an immune response in the body to treat sarcoma. Before receiving the NY-ESO-1 TCR/IL-15 NK dose, patients undergo a process to deplete existing T-cells, setting the stage for the new therapy.
Over the following 12 months, twelve scheduled visits to the study doctor will be required, with most appointments expected to occupy a whole day for standard sarcoma-related testing. Patient support services provided for travel for the appointments.
Clinicaltrials.gov: https://clinicaltrials.gov/study/NCT06083883?cond=synovial%20sarcoma&term=TCR-NK&rank=1
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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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Leiomyosarcoma
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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Undifferentiated Pleomorphic Sarcoma| Myxofibrosarcoma
ENVASARC: ENVAFOLIMAB AND ENVAFOLIMAB WITH IPILIMUMAB IN PATIENTS WITH UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA (ENVASARC)
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04480502?term=envafolimab&draw=4
Sponsor website: www.traconpharma.com
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Fibrocartilaginous Mesenchymoma| Angiosarcoma
PHASE 1 TRIAL OF THE LSD1 INHIBITOR SECLIDEMSTAT (SP-2577) WITH AND WITHOUT TOPOTECAN AND CYCLOPHOSPHAMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY EWING SARCOMA AND SELECT SARCOMAS
This is an open label, phase I trial to evaluate the safety of an orally administered targeted agent, seclidemstat (LSD1 inhibitor) in combination with cyclophosphamide and topotecan, in patients with relapsed or refractory Ewing sarcoma who have received at least one line of prior treatment for Ewing sarcoma. The trial also enrolls both myxoid liposarcoma and Ewing-related sarcomas which share a similar translocation gene as Ewing sarcoma, who have received at least two prior lines of treatment for their sarcoma. The myxoid liposarcoma and translocated sarcoma patients will be enrolled to single-agent seclidemstat. This trial has completed the dose escalation phase of the trial and is now in dose expansion. The primary objective is safety and tolerability of seclidemstat, alone, and in combination with standard chemotherapy.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03600649?term=salarius&draw=2&rank=2
Sponsor Website: http://salariuspharma.com/
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