CURE's Clinical Trial Corner

As the cancer treatment landscape continues to grow, patients and their caregivers should be aware of the various clinical trials currently being conducted — and ones they can possibly join.

Here is a list of the recent trial initiations that occurred in July.

Non-Small Cell Lung Cancer

Calithera Biosciences initiated a phase 1/2 trial, designed to evaluate the safety and anti-tumor activity of telaglenastat in combination with Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) for the treatment of patients with KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. Telaglenastat is designed to block glutamine consumption in tumor cells —genetic alterations like KRAS can cause cancer cells to increase metabolism of glutamine. Therefore, the drug is intended to prevent the enzyme from being able to metabolize and survive. The first patient in the trial was dosed on July 2, 2019.

Colorectal Cancer

On July 9, 2019, Trovagene, Inc. initiated patient enrollment for its phase 1b/2 study of onvansertib in combination with a combination of chemotherapy drugs, called FOLFIRI, and Avastin (bevacizumab) for the second-line treatment of patients with metastatic colorectal cancer with a KRAS mutation. Onvansertib is an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor that helps to stop tumor cell division. The trial is being conducted at USC Norris Comprehensive Cancer Center, Hoag Cancer Center and The Mayo Clinic.

GNAQ/11 Mutations or PRKC Fusions

A phase 1/2 study of IDE196 to treat patients with solid tumors who are harboring GNAQ/11 mutations or PRKC fusions began in June. IDE196 is a potent small molecule protein kinase C (PKC) inhibitor — designed to bind to and inhibit PKC, which prevents the activation of PKC-mediated signaling pathways and may lead to the induction of cell cycle arrest and the death of cells in susceptible tumor cells. Clinical sites are now enrolling in the US and Australia.

Chronic Myeloid Leukemia

Ascentage Pharma will be starting a phase 1b study of HQP1351 as treatment for patients with tyrosine kinase inhibitors-resistant chronic myeloid leukemia. The trial initiation follows Food and Drug Administration clearance of the company’s investigational new drug application. HQP1351 is designed to address the acquired drug resistance from the treatment using Gleevac (imatinib) — which occurs in 20% to 30% of patients treated with the chemotherapy, highlighting an unmet need in this patient population.