CURE's Clinical Trial Corner: March 2020

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.

Liver Cancer

Medivir AB has dosed the first patient with advanced liver cancer in a phase 1b study to assess the safety and tolerability of MIV-818, a liver-targeted, orally administered therapy.

The researchers also hope to analyze the efficacy of the drug.

“Patients with advanced liver cancer have limited treatment options and the unmet medical need is large,” Medivir CEO Dr. Uli Hacksell said in a press release. “Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase 1a, we hope to get additional supportive data from the phase 1b study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."

Melanoma

The first patient was dosed in a phase 1b trial to evaluate the safety, tolerability and antitumor activities of IN10018 (InxMed) as a monotherapy and in combination with Cotellic (Cobimetinib) in patients with metastatic uveal melanoma and NRAS mutant metastatic melanoma.

“InxMed's IN10018 could be a promising treatment agent for the metastatic melanoma patients,” Dr. Sapna Patel, of The University of Texas MD Anderson Cancer Center, said in a press release. "We feel excited to collaborate with InxMed to have first patient dosed in MD Anderson cancer center and look forward to advancing it quickly to see clinical benefit.”

The open label study will be conducted across six sites in the United States, including The University of Texas MD Anderson Cancer Center, and three sites in Australia.

Acute Myeloid Leukemia

A new first-in-human phase 1 study that is designed to assess the safety and activity of UniCAR-T-CD123, a UniCAR cellular immunotherapy platform, in patients with CD123-positive relapsed/refractory Acute Myeloid Leukemia (AML) has collected blood samples from its first patient.

The trial will include up to 16 CD123-positive patients with relapsed/refractory Acute Leukemias to examine the feasibility, safety and potential efficacy of the combined application of a single dose of UniCAR-T and the continuous infusion of the CD123-specific targeting module TM123

Lung Cancer

The National Comprehensive Cancer Network (NCCN), through its Oncology Research Program, has launched three research projects with an emphasis on improving health care provider performance and/or health care quality in the treatment of advanced non-small cell lung cancer.

“Lung cancer is still the number one cause of cancer death in the United States,” Dr. Wui-Jin Koh, Chief Medical Officer of the NCCN, said in a press release. “We’ve seen rapid and robust progress in treating this cancer recently, and it’s having a significant impact on reducing mortality. Now we want to make it easier for medical practices to implement these innovations and make sure they’re reaching every patient who could benefit from them.”

The projects, which will be funded through a collaboration with AstraZeneca, will take place at Hospital of the University of Pennsylvania, Massachusetts General Hospital Cancer Center and University Hospitals — Seidman Cancer Center. The projects are expected to begin in the third quarter of 2020 and last for two years.