Trial Summary
What is the purpose of this trial?A Phase IIa open label study evaluating the preliminary efficacy of intratumoural tigilanol tiglate in advanced and/or metastatic soft tissue sarcoma of the extremities and body wall.
What safety data is available for Tigilanol Tiglate in treating soft tissue sarcoma?The provided research does not contain specific safety data for Tigilanol Tiglate, Stelfonta, or EBC-46 in the treatment of soft tissue sarcoma. The studies mentioned focus on other treatments such as tasisulam sodium, brostallicin, and ecteinascidin-743. Therefore, additional sources should be consulted to find safety data for Tigilanol Tiglate.23567
Is the drug Tigilanol Tiglate a promising treatment for soft tissue sarcoma?The information provided does not directly mention Tigilanol Tiglate, so we cannot determine if it is a promising treatment for soft tissue sarcoma based on the given research articles.12349
What data supports the idea that Intratumoral Tigilanol Tiglate for Soft Tissue Sarcoma is an effective treatment?The available research does not provide specific data on the effectiveness of Intratumoral Tigilanol Tiglate for Soft Tissue Sarcoma. Instead, it focuses on other treatments and factors related to soft tissue sarcomas, such as the use of ecteinascidin-743 (ET-743) and the development of prediction models for treatment decisions. Therefore, there is no direct evidence from the provided information to support the effectiveness of Tigilanol Tiglate for this condition.237810
Do I have to stop taking my current medications for the trial?The trial requires a 28-day washout period for any systemic anticancer therapy or investigational agents before starting the study drug. Other medications are not specifically mentioned, so consult with the study team for guidance.
Eligibility Criteria
Adults with advanced soft tissue sarcoma in limbs or body wall, able to consent and follow study rules. They must have a life expectancy over 12 weeks, be relatively active (ECOG ≤ 2), and not pregnant or breastfeeding. Participants need functioning kidneys and liver, agree to use contraception, and can't have major blood vessel tumors or recent treatments that conflict with the trial.Treatment Details
The trial is testing Tigilanol Tiglate's effectiveness when injected directly into tumors of patients with advanced soft tissue sarcomas. It's an open-label Phase IIa study meaning everyone gets the treatment and both doctors and participants know what's being given.
1Treatment groups
Experimental Treatment
Group I: Single Arm, Open LabelExperimental Treatment1 Intervention
Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.
Tigilanol Tiglate is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Stelfonta for:
- Non-resectable, non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock, and non-resectable, non-metastatic cutaneous mast cell tumors in dogs
🇺🇸 Approved in United States as Stelfonta for:
- Non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs) and non-metastatic MCTs located under the dog's skin (subcutaneous), in particular areas of a dog's leg
Find a clinic near you
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CentreNew York, NY
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Who is running the clinical trial?
QBiotics Group LimitedLead Sponsor
References
Edatrexate in patients with soft tissue sarcoma. Activity in malignant fibrous histiocytoma. [2019]Chemotherapy has had little impact on the natural history of soft tissue sarcoma, and often is associated with serious toxicity. Edatrexate, an investigational antifolate, is active in patients with lung cancer, and has cytotoxic activity in human sarcoma cell lines.
Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. [2018]A multicenter phase II study evaluating efficacy, safety, and pharmacokinetics of ecteinascidin-743 (ET-743) in pretreated advanced soft tissue sarcoma patients.
Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. [2018]This nonrandomized multicenter phase II study was performed to evaluate the activity and safety of Ecteinascidin (ET-743) administered at a dose of 1.5 mg/m(2) as a 24-hour continuous infusion every 3 weeks in patients with pretreated advanced soft tissue sarcoma.
Suppression of soft tissue sarcoma growth by a host defense-like lytic peptide. [2021]Soft tissue sarcoma (STS) is an anatomically and histologically heterogeneous neoplasia that shares a putative mesenchymal cell origin. The treatment with common chemotherapeutics is still unsatisfying because of association with poor response rates. Although evidence is accumulating for potent oncolytic activity of host defense peptides (HDPs), their potential therapeutic use is often limited by poor bioavailability and inactivation in serum. Therefore, we tested the designer host defense-like lytic D,L-amino acid peptide [D]-K3H3L9 on two STS cell lines in vitro and also in an athymic and syngeneic mouse model. In recent studies the peptide could show selectivity against prostate carcinoma cells and also an active state in serum.
A phase II study of tasisulam sodium (LY573636 sodium) as second-line or third-line treatment for patients with unresectable or metastatic soft tissue sarcoma. [2021]Tasisulam sodium (hereafter tasisulam), a novel anticancer agent, is being studied in a broad range of tumors. The primary objective of this phase II study was to determine progression-free survival (PFS) in patients with 1 or 2 prior chemotherapy regimens for unresectable/metastatic soft tissue sarcoma (STS). Secondary objectives included objective response rate (ORR), clinical benefit rate (CBR), overall survival (OS), pharmacokinetics, and safety.
Brostallicin versus doxorubicin as first-line chemotherapy in patients with advanced or metastatic soft tissue sarcoma: an European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group randomised phase II and pharmacogenetic study. [2022]Brostallicin is a DNA minor groove binder that has shown activity in patients with soft tissue sarcoma (STS) failing first-line therapy. The present study assessed the safety and efficacy of first-line brostallicin in patients with advanced or metastatic STS >60 years or not fit enough to receive combination chemotherapy. A prospective explorative pharmacogenetic analysis was undertaken in parallel.
[Molecular biology of sarcoma and therapeutic choices]. [2018]Soft tissue sarcomas (STS) are a set of very heterogeneous tumors with numerous histological categories. The development of the molecular biology allowed identifying recurring molecular anomalies in certain subgroups of sarcomas, being able to represent diagnostic, prognosis and therapeutic tools. The molecular classification of STS includes until today 5 main groups of abnormalities: sarcomas with "simple genomic profile" showing reciprocal (1) chromosomal translocations, (2) activating mutation, (3) inhibitive mutation or (4) simple amplification; (5) sarcomas with "complex genomic profile" can include several tens of molecular abnormalities. The development of new-targeted therapies is based on the identification of a target, specific of a tumors subgroup and involved in carcinogenesis mechanisms and/or tumoral growth. Then, the aim of clinical research is to establish the proof of the concept through clinical trials, demonstrating the benefit brought to the patient and ending in the marketing of the drug. This proof of the concept was clearly established for imatinib, sunitinib and regorafenib in gastrointestinal stromal tumors, for imatinib in dermatofibrosarcoma protuberans and pigmented vilo-nodular synovitis, for denosumab in giant cell tumors of the bone, ending in the authorization to use these new therapies in these indications. It is in progress and promising for anti-IGF-1R in Ewing sarcomas, for crizotinib in myofibroblastic inflammatory tumors, for mTOR inhibitor in PEComas... The role of molecular abnormalities identified in the mechanisms of tumoral progress for sarcomas and their potential therapeutic impact will be detailed.
A prediction model for treatment decisions in high-grade extremity soft-tissue sarcomas: Personalised sarcoma care (PERSARC). [2018]To support shared decision-making, we developed the first prediction model for patients with primary soft-tissue sarcomas of the extremities (ESTS) which takes into account treatment modalities, including applied radiotherapy (RT) and achieved surgical margins. The PERsonalised SARcoma Care (PERSARC) model, predicts overall survival (OS) and the probability of local recurrence (LR) at 3, 5 and 10 years.
Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study. [2022]To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) based chemotherapy in patients with sarcoma.
Management of Soft Tissue Sarcomas in Extremities: Variation in Treatment Recommendations and Surveillance According to Specialty and Continent. [2022]This study aimed to provide an insight into clinical decision-making and surveillance strategy of sarcoma specialists for patients with primary soft tissue sarcoma of the extremities (eSTS). The secondary aim was to quantify the role of patient- and tumor-specific factors in the perioperative management.