Tag: soft tissue sarcoma

Thermosome Initiates Final Dose Level in Phase I Trial of Lead Compound THE001

— Independent Data Safety Monitoring Board declared dose level 2 as safe and recommended escalation to final dose level 3

Thermosome, a drug development company focused on targeted tumor therapies, today announced its ongoing Phase I trial has progressed to dose level 3 (DL3) after the independent Data Safety Monitoring Board (DSMB) declared dose level 2 (DL2) as safe and recommended escalation to the final dose level (DL3). In the trial, the Company’s lead compound THE001is tested in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS) in combination with regional hyperthermia. Read more…

Thermosome Presents Encouraging Initial Clinical Data from Phase I Trial of Lead Compound THE001

— THE001 safe and well tolerated in first two dose level, demonstrating encouraging signs of clinical activity

— Data presented at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024

Thermosome, a drug development company focused on targeted tumor therapies, today announced encouraging initial clinical data from the ongoing Phase I study of its lead compound THE001 in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS). The data were presented as a poster (#P410) titled “Phase I study of THE001 (DPPG2-TSL-DOX) combined with regional hyperthermia in patients with locally advanced or metastatic soft tissue sarcoma at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024 in San Diego, USA. Read more…

Company News: Nanobiotix Starts Clinical Trial with Lead Product NBTXR3

– A Completely New Cancer Treatment to Be Tested in Patients with Soft Tissue Sarcoma –

Nanobiotix, a company developing novel cancer nanotherapeutics, announced today that its lead compound NBTXR3 has received the formal authorization from the French Medicine Agency, AFSSAPS[1], to start the first clinical trial[2].

27 patients diagnosed with soft tissue sarcoma will be enrolled in the Phase I study and will receive NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment) (www.clinicaltrial.gov). The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety. Preliminary data are expected by the end of 2012.

The trial is a prospective, open-label, dose-escalation, single arm, non-randomized trial. NBTXR3 will be administered to the patients prior to surgery by a single intra-tumoral injection followed by standard radiotherapy procedure. After completion of the regular treatment procedure, the patients will undergo surgery to resect the soft tissue sarcoma. Along with the safety and feasibility endpoints, the primary tumor tissue will then be available for the evaluation of the pathological response rate.

Further clinical trials are in preparation in Europe and in the US. NBTXR3 has been classified in the EU as class III medical device. In the US, it has been classified as a drug by the FDA.

NBTXR3, the most advanced compound of Nanobiotix´ NanoXray pipeline, is intended to enhance the local destruction of the tumor mass during radiotherapy. NBTXR3 is a nanoparticle consisting of hafnium oxide crystals. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.

Local treatment of malignant tumors is a cornerstone of cancer therapy. The standard treatments are surgery and radiotherapy, either as a stand-alone treatment or in combination. Radiotherapy has been widely used across most oncology indications for decades. About 50 to 60% of all cancer patients undergo radiotherapy treatment as part of existing treatment guidelines. All NanoXray products are compatible with these guidelines and do not require changes of surgery and radiotherapy procedures. Moreover, NanoXray products can be used with any existing standard radiation equipment available in almost every hospital world-wide.


[1] Agence Française de Sécurité Sanitaire des Produits de Santé

[2] Clinical trial, registration number RCB 2011-A00342-39