With all patients with solid tumors enrolled in the phase 1 study of QBS72S, 2 more studies evaluating the agent in brain malignancies will commence.
Trial Name: Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
ClinicalTrials.gov Identifier: NCT04430842
Sponsor: Quadriga Biosciences, Inc.
Completion Date: December 2022
A phase 1 study evaluating QBS72S in patients with solid tumors (NCT04430842) has completed its enrollment, according to Quadriga BioSciences.1
Preclinical research has already shown the agent to substantially reduce tumor growth and boost survival in a triple negative breast cancer spontaneous brain metastasis model and in orthotopic glioblastoma multiforme models.2
QBS72S is a novel, first-in-class chemotherapeutic agent which mimics an aromatic amino acid for cellular uptake by the amino acid transporter L-type amino acid transporter 1 and enables the agent to cross the blood brain barrier. Further, it is able to selectively target numerous types of rapidly growing cancer cells. When it is inside the cell, QBS72S causes double-stranded DNA to break, which results in cell death.
"Completing the enrollment of our dose-ranging Phase 1 study is an important milestone in the development of QBS72S," said Gordon Ringold, PhD, chief executive officer of Quadriga BioSciences. "With the study complete, Quadriga is able to launch 2 phase 2 studies investigating QBS72S for brain malignancies, each of which is supported by funding from an SBIR grant. We are fortunate for the support of all involved as we continue to advance QBS72S development."
The phase 1, multicenter, open-label, dose-escalation study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS72S in patients with advanced or metastatic solid tumors.3
Those enrolled on the trial will receive intravenous administration of QBS10072S once every 4 weeks. The dose level will start at 3mg/m2 and increase in subsequent cohorts.
Patients were required to be aged 18 years and older with a histological or cytological diagnosis of an advanced or metastatic solid tumor to be eligible for enrollment in the trial. Further inclusion criteria required patients to be intolerant to standard treatment, resistant to standard therapy, or have no curative therapy available to them. Further, patients must have had adequate bone marrow function, renal function, and liver function, an ECOG performance status of 0-2, at least 1 measurable lesion, and resolved acute adverse events (AEs) of any prior therapy to baseline severity or CTCAE grade 0-1, except for AEs not constituting a safety risk by Investigator judgment.
The primary end point of the study is to determine the MTD of the agent with secondary end points including safety and tolerability, peak plasma concentration, area under the plasma concentration vs time curve, half-life of QBS72S in plasma, and time to maximum concentration of QBS72S in plasma.
With enrollment complete in this phase 1 study, the recommended phase 2 dose has been informed for 2 more trials which will examine QBS72S in patients with brain malignancies.
The first will investigate QBS72S for the potential treatment of brain metastases in patients with triple negative breast cancer at Stanford University (NCT05305365) and the other will evaluate QBS72S for the potential treatment of patients with glioblastoma at the Dana-Farber Cancer Institute (NCT02977780).
Both studies are expected to launch by the end of 2022.
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