The investigational medicine tinostamustine (EDO-S101), developed by Mundipharma EDO GmbH, is now being tested in patients with advanced solid tumors, including ovarian cancer, in a first-in-human Phase 1/2 clinical trial.
The trial will assess the safety, tolerability, and effectiveness of the new treatment in participants recruited at Stanford University, Cedars Sinai Medical Center in Los Angeles, California, and The Mayo Clinic in Scottsdale, Arizona.
“Following the initial Phase 1 study in hematological malignancies [NCT02576496], I am delighted that EDO is now embarking on a further clinical trial in solid tumors,” Thomas Mehrling, MD, PhD, said in a press release. Mehrling is CEO of EDO.
Tinostamustine is an alkylating deacetylase inhibiting molecule that binds to the genetic content of cancer cells, promoting DNA damage and, at the same time, counteracting any attempts of DNA damage repair by the cancer cells. Preclinical studies have suggested that this mode of action has the potential to overcome resistance to therapy, promoting cancer cell death more effectively than traditional DNA-damaging therapies .
The investigatational drug has demonstrated potential to effectively target small cell lung cancer (SCLC) cells, soft tissue sarcoma (STS) or non-KIT gastrointestinal stromal tumors (GIST), triple negative breast cancer (TNBC), and ovarian cancer.
“People with advanced solid tumors can become resistant to treatment and often have a relatively poor chance of survival. Breaking through resistance is essential if we are to continue to address unmet needs in oncology,” Mehrling said. “This is a key step in the investigation of a first-in-class treatment, which we hope will prove a vital addition for patients with limited current options.”
Phase 1 of the new trial will attempt to assess the safety, tolerability, maximum dose, and optimal dosing schedule of tinostamustine as a single agent. For this initial evaluation, the study will enroll patients with solid tumors who have not responded to at least one prior line of therapy and have no other available therapies.
Upon determination of the optimal dose and regimen to be used, investigators will evaluate the treatment-related toxicity and effectiveness in the Phase 2 part of the study.
It’s primary objective is to evaluate objective response rate and clinical benefit rate, but investigators also will evaluate the safety, progression-free survival, overall survival, and duration of response. This part of the study will include patients with selected relapsed/refractory solid tumors, which will include SCLC, STS or GIST, TNBC, and ovarian cancer.