CURE's Clinical Trial Corner: September 2019

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 September.

Prostate Cancer

Mustang Bio, Inc., has opened a phase 1 trial, designed to evaluate MB-105 in men with prostate cancer, and is enrolling patients at City of Hope in Duarte, California. The clinical trial of MB-105, a prostate stem cell antigen chimeric antigen receptor (CAR)-T technology, is one of the first CAR-T trials for prostate cancer in the nation. It is enrolling up to 33 patients.

In this portion of the study, researchers will be evaluating the side effects and best dose of the prostate stem cell antigen CAR-T cells among men with prostate stem cell antigen-positive castration-resistant prostate cancer that has metastasized to other parts of the body.

“Patients with advanced prostate cancer are in urgent need of a therapy that could provide a more durable remission,” said principal investigator Dr. Tanya Dorff, an associate clinical professor in the Department of Medical Oncology and Therapeutics Research and the head of the genitourinary cancers program at City of Hope. “CAR-T cell therapy has cured some cancers that are difficult to treat, and we want to know if we can do that for prostate cancer. Our hope is that this CAR-T cell therapy can be a game changer for these patients.”

Metastatic Pancreatic Cancer

Tyme Technologies, Inc., has commenced the pivotal stage of the phase 3 TYME-88-PANC study — designed to evaluate the clinical benefits of oral SM-88 (racemetyrosine) as a third-line treatment for patients with metastatic pancreatic cancer. In phase 2 of the study, the agent demonstrated encouraging overall survival trends in patients with advanced pancreatic cancer. In addition, SM-88 has demonstrated responses in 15 different cancer types across four separate studies.

Enrollment is expected to begin in the fourth quarter of 2019 at leading pancreatic cancer research centers across the United States.

Cervical Cancer

FirstHealth of the Carolinas enrolled its first patient to the randomized, blinded, non-comparative, two-arm phase 2 clinical trial to assess the efficacy and safety of AGEN203 (an anti-PD-1 agent), administered alone or in combination with AGEN1884 (an anti-CTLA-4 drug), for the treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line, platinum-based chemotherapy. Seventy sites are expected to participate globally with 50 of those in the United States, representing a total of approximately 200 participants.

Throughout a two-year cancer treatment period, patient enrolled in the trial will be monitored for potential side effects and their response to therapy. In turn, those results will be shared with the clinical trial sponsors and aggregated with those of other trial to determine which treatment protocol is more effective.

“One of the key benefits expected from the combination of anti-CTLA-4 and anti-PD-1 is the anticipated improvement in response rates and duration of response for patients,” explained study investigator Dr. Michael Sundborg, a gynecologic oncologist at FirstHealth.

AML/MDS

Selvita dosed the first patient enrolled in its phase 1b clinical trial of SEL120 for patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The open-label, dose-escalation study — designed to evaluate safety, tolerability and the preliminary activity of SEL120, as well as establishing a recommended dose for further clinical development – will be conducted at multiple sites in the U.S.

Patients will be enrolled in the study, which will also assess pharmacokinetic and pharmacodynamic parameters of SEL120, independent of specific tumor mutational burden.