CURE’s Clinical Trial Corner: December 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.

Acute Myeloid Leukemia

The first patient has been dosed in an ongoing phase 1/2 trial of RTX-240, an allogenic cell therapy product candidate, for the treatment of patients with relapsed/refractory or locally advanced solid tumors or relapsed/refractory acute myeloid leukemia (AML), according to the product’s manufacturer, Rubius Therapeutics.

The open label, multicenter, first-in-human dose-escalation study consists of two phase 1 dose-escalation arms: one in patients with relapsed/refractory AML and the other in patients with relapsed/refractory or locally advanced solid tumors. The phase 1 portion of the trial is expected to determine safety and tolerability, pharmacokinetics (how a drug is absorbed, distributed, metabolized and excreted), a maximum tolerated dose and a recommended dose of RTX-240 for the phase 2 portion of the trial.

“Despite advances in the management of AML, the overall outcome for patients with relapsed or refractory disease remains quite poor due to several factors, including lack of disease response to salvage therapy and the overall toxicity of the therapies,” said Dr. Alexander Spira, M.D., Ph.D., director of the Virginia Cancer Specialists Research Institute and the phase 1 portion of the trial, in a press release.

“RTX-240 potentially offers a novel way of treating relapsed/refractory AML by using the body’s own immune system to attack cancer. We look forward to working with Rubius Therapeutics on this differentiated approach to treating AML.”

Solid Tumors

The first patient has been dosed in a phase 2 trial of VLS-101 for the treatment of patients with solid tumors, according to the product’s manufacturer, VelosBio.

“VLS-101 dosing of the first patient in our phase 2 solid tumor trial represents a key milestone for our lead ROR1-directed clinical program,” said VelosBio’s chief executive officer Dave Johnson in a company-issued press release.

“Based on the broad expression of ROR1 across different cancer types, and our pre-clinical data showing VLS-101 antitumor activity in solid tumors, we are excited to advance this investigational candidate as a potential new therapy for difficult-to-treat cancers.”

The phase 2 trial is expected to enroll patients with previously treated solid tumors, including breast cancer, lung cancer, and other cancers that may express ROR1, which is a cell-surface protein that is expressed during a fetuses development but generally disappears before birth. However, the protein may reappear on cancerous tissues, including on solid tumors.

Diffuse Large B-Cell Lymphoma

Genmab recently announced that it will begin a phase 3 trial to evaluate the safety and efficacy of subcutaneous Epcoritamab compared to one of two chemotherapy regimens in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

“In collaboration with AbbVie, we have planned a broad, expansive, accelerated epcoritamab clinical development plan to maximize the potential of this promising bispecific antibody, with the ultimate goal of bringing new differentiated treatment options as soon as possible to patients. We look forward to the data from this first phase 3 trial, especially for relapsed or refractory DLBCL patients as it remains an area of high unmet medical need,” said Genmab’s chief executive officer Jan van de Winkel in a press release.

The open-label trial is expected to enroll approximately 480 patients with the condition who have failed or are ineligible for autologous stem cell transplant. Patients will be randomized to either receive the study drug or bendamustine and Rituxan (rituximab) or gemcitabine, oxaliplatin and Rituxan. The main goal of the study, according to the release, is to measure overall survival.

Head and Neck Cancer

A phase 2 trial to evaluate the combination of PDS0101 and Keytruda (pembrolizumab) for the firstline treatment of patients with HPV16-positive head and neck cancer that has returned or spread is now open for enrollment, according to PDS Biotechnology Corporation.

The multi-center, open label, single arm, non-randomized trial is expected to enroll approximately 100 patients across 25 sites in the United States. The goal of the study, according to the release, is to evaluate the safety and efficacy of PDS0101, an immunotherapy that targets HPV-associated cancers, in combination with Keytruda in this patient population. The primary goal of the study will be to assess the objective response rate (the proportion of patients who had a complete or partial response to treatment) nine months after the start of combination treatment.

“We are thrilled to offer our patients with recurrent or metastatic head and neck cancer such an exciting and potentially safe treatment option,” said Dr. Timothy Panella, the primary investigator of the phase 2 trial at the University of Tennessee Medical Center, in a press release. “This type of combination approach is attractive to patients and offers a novel targeted therapy in the fight against this very challenging disease.”