Switzerland-based Mundipharma EDO has initiated a Phase I/II clinical trial of tinostamustine (EDO-S101) to treat patients with advanced solid tumours in the US.
Tinostamustine is an alkylating deacetylase inhibiting (AK-DACi) molecule that has demonstrated an ability to improve access to DNA strands in cancer cells, break them and counteract damage repair during preclinical studies.
The multi-centre Phase I/II trial is being conducted at Stanford University, Cedars Sinai Medical Centre in Los Angeles and the Mayo Clinic in Scottsdale.
Mundipharma EDO CEO Dr Thomas Mehrling said: "Following the initial Phase I study in haematological malignancies, I am delighted that EDO is now embarking on a further clinical trial in solid tumours.
“Breaking through resistance is essential if we are to continue to address unmet needs in oncology.
“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."
The primary objective of the Phase I part of the trial is evaluation of safety, tolerability, maximum-tolerated dose (MTD) and recommended Phase II dose (RP2D) of tinostamustine as a monotherapy.
While the trial’s secondary objective is pharmacokinetic (PK) profile, the exploratory objective is extent of gene expression changes in tumour samples with anti-tumour activity.
The Phase II part of the trial will include cohorts of patients with specific solid tumours such as small cell lung cancer (SCLC), soft tissue sarcoma (STS), non-KIT gastrointestinal stromal tumours (GIST), triple negative breast cancer (TNBC) and ovarian cancer.
The primary objectives are objective response rate (ORR) and clinical benefit rate (CBR), while the secondary objectives include safety, progression-free survival, overall survival, duration of response and PK profiles.