CURE’s Clinical Trial Corner: August 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.

HER2-Expressing Solid Tumors

Acepodia announced the first patient has been dosed in an open-label phase 1 trial of ACE1702 to treat HER2-expressing solid tumors.

The trial is designed to evaluate the safety and tolerability, pharmacodynamics and preliminary efficacy of ACE1702, a natural killer cell therapy. It is expected that anywhere from 12 to 24 patients will be enrolled in the study.

“Today, treatments for solid tumors are severely limited in their effectiveness due to an inability to overcome the immunosuppressive tumor microenvironment, and Acepodia’s technology could represent a solution to this long-standing therapeutic obstacle,” said Acepodia’s senior vice president of research and development Dr. Mark Gilbert in a press release. “We look forward to advancing ACE1702 in the clinic and exploring the potential of our unique approach to cell therapies for the treatment of solid tumors, which constitute 90% of new cancer cases per year.”

Breast Cancer

The Baylor College of Medicine is enrolling patients in a study that will use a high-resolution imaging system to collect images of breast tumors to develop artificial intelligence.

“One of the big problems in breast cancer surgery is that in about one in four women on whom we do a lumpectomy to remove cancer, we fail to get clear margins,” said Dr. Alastair Thompson, section chief of breast surgery at Baylor College of Medicine, in a press release. “That in turn leads to a need for reoperation to avoid high recurrence rates. Hence the need for a good, effective and user-friendly tool to help us better identify if we have adequately removed the breast cancer from a woman’s breast, to get it right the first time.”

Researchers plan to enroll approximately 400 patients into the study; however, the study is only open to patients at the Dan L. Duncan Comprehensive Cancer Center at Baylor St. Luke’s Medical Center.

“This could be a huge improvement for patient care. It could help patients avoid a second surgery and the physical, emotional and financial stress that accompany an additional procedure,” said Thompson.

HPV-Associated Cancers

Precigen announced the first patient was dosed in a phase 1 trial of PRGN-2009 to help activate the immune system to recognize and target HPV-positive solid tumors.

The phase 1 portion of the trial is designed to evaluate the safety of PRGN-2009 as a monotherapy and determine the recommended dose for phase 2 trial followed by an evaluation of the recommended dose and M7824 (bintrafusp alfa). The phase 2 portion is expected to evaluate PRGN-2009 either alone or in combination with M7824 in patients with newly diagnosed stage 2/3 HPV16-positive oropharyngeal cancer.

“We appreciate working in collaboration with such renowned partners at the (National Cancer Institute) to achieve this important milestone in our efforts to develop a new off-the-shelf immunotherapy treatment option for patients with HPV-associated cancers,” said Precigen’s president and CEO Helen Sabzevari in a press release.

Ovarian Cancer and Mesothelioma

An ongoing phase 1 trial of MCY-M11 has been expanded to include a new parallel cohort of patients and new additional clinical sites, according to MaxCyte, the agent’s manufacturer.

The new cohort is expected to evaluate MCY-M11 delivered through the peritoneum at escalating doses in more patients with relapsed/refractory ovarian cancer and malignant peritoneal mesothelioma.

Massachusetts General Hospital/Harvard Medical School and Hackensack University Medical Center are joining the National Cancer Institute and Washington University in St. Louis as clinical sites for the trial.

“We are very pleased with the progress of this first-in-human trial to date, and have great hopes that we are moving closer towards bringing a more effective immunotherapeutic option for patients with solid tumors,” said MaxCyte’s chief medical officer Dr. Claudio Dansky Ullmann in a press release.