CURE's Clinical Trial Corner: May 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.

CURE^® has gathered a list of some of the most interesting trials happening across the cancer landscape that have just begun for patients with various types of cancer.

Non-Small Cell Lung Cancer

WindMIL Therapeutics has begun enrolling patients in a portion of a multi-center phase 2a clinical trial to assess the safety and efficacy of marrow-infiltrating lymphocytes (MILs) in patients with locally advanced unresectable or metastatic non-small cell lung cancer who are refractory to, or have relapsed on an anti-PD-1-containing regimen.

In this portion of the trial, approximately 20 patients will receive MILs plus Opdivo (nivolumab). Objective response rate will be the study’s main outcome. Additional secondary outcomes include duration of response, progression free survival and overall survival.

MILs - NSCLC is an adoptive cell therapy product aimed at activating and expanding T cells derived from the bone marrow of patients with NSCLC.

Burkitt’s Lymphoma/Leukemia

Rafael Pharmaceuticals has expanded its phase 2 clinical trial evaluating CPI-613® (devimistat) for patients with relapsed or refractory Burkitt’s lymphoma/leukemia.

The University of Texas MD Anderson Cancer Center will begin enrolling patients and Dr. Raphael Steiner will serve as principal investigator. Dr. Ariela Noy, of Memorial Sloan Kettering Cancer Center, is heading the trial. City of Hope and Massachusetts General Hospital are also enrolling patients.

“The aggressive nature of both double/triple hit lymphomas and Burkitt’s lymphoma, the limited treatment options and the high rate of relapse has made it difficult to effectively treat these patients,” Noy said in a press release. “These are rare diseases, making the expansion of this trial to other sites so encouraging.”

CD36 Expressing Tumors

The first patient has been dosed in a phase 1b/2 trial evaluating the efficacy, safety and tolerability of VT1021, a small peptide with dual targeting activities of CD36 and CD47, across five cancer types.

The goal is to enroll 15 patients each with ovarian cancer, pancreatic cancer, triple negative breast cancer, glioblastoma, and a tissue agnostic group of patients with high CD36 expressing tumors.

“The … approach of VT1021 is to induce tumor microenvironment production of Tsp-1, which is a high affinity ligand of two key receptors with potent downstream antitumor activities, CD36 and CD47. As opposed to targeting only one receptor, like CD47, VT1021 exploits multiple antitumor mechanism s that contribute to tumor cell death and immune response enhancement,” Dr. Lou Vaickus, interim chief medical officer of Vigeo Therapeutics, said in a press release. “This approach may be beneficial as a monotherapy as well as in combination with other agents, particularly in the classic "cold" tumor environment.”

Metastatic Castration-Resistant Prostate Cancer

The first patient has been dosed in phase 1 clinical trial evaluating P-PSMA-101, an autologous CAR-T therapeutic candidate, in patients with metastatic castration-resistant prostate cancer.

“Extending our gene engineering technology to solid tumors represents the next opportunity in oncology where we believe our proprietary platforms and approach have advantages over others in the space," Dr. Eric Ostertag, chief executive officer of Poseida Therapeutics, said in a press release.

Patients will be separated into cohorts and receive single and multiple doses of the study drug to determine the best dose and fewest side effects.