CURE's Clinical Trial Corner: November 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.

Head and Neck Cancer

Sensei Biotherapeutics, Inc. announced the dosing of the first patient in its phase 1/2 clinical trial, designed to evaluate SNS-301 — a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β‑hydroxylase (ASPH) – in patients with ASPH‑positive head and neck cancer who have previously received immune checkpoint inhibitors. The multicenter, open-label trial is evaluating the safety, preliminary efficacy and immunogenicity of SNS-301 in combination with Keytruda (pembrolizumab). The primary efficacy endpoints of the study include objective response rate (complete and partial responses to therapy), duration of response and multiple secondary endpoints measuring immune responses.

The company expects to enroll approximately 30 patients in its two-stage trial. “Targeting ASPH represents a novel strategy for treating cancer and we believe that SNS-301 has potentially broad applicability across a wide variety of cancers with its unique mechanism combined with checkpoint inhibition. We look forward to providing preliminary results at a major medical meeting in 2020,” Dr. Ildiko Csiki, consulting chief medical officer of Sensei Biotherapeutics, said in a press release.

Ovarian Cancer

Celsion Corporation has completed its safety review of data from the first eight patients enrolled in the ongoing phase 1/2 OVATION 2 study and will proceed with completing enrollment in the phase 1 portion of the trial. The trial is designed to evaluate the safety of GEN-1, an IL-12 gene-mediated immunotherapy, in combination with the standard of care for the treatment of newly diagnosed patients with stage 3 and 4 ovarian cancer who will undergo standard neoadjuvant chemotherapy followed by interval debulking surgery.

“OVATION 2 is designed to define the optimal dose of GEN-1 and provide important insights into GEN-1's clinical benefit as an adjuvant therapy both before and after debulking surgery with the potential to stimulate an anticancer immune response, compared to the current standard of care alone,” Dr. Nicholas Borys, executive vice president and chief medical officer of Celsion, said in a press release.

The trial will enroll up to 130 patients with Stage 3/4 ovarian cancer, with 12 to 15 patients in the phase 1 portion and up to 118 patients in the phase 2 portion.

Melanoma

CytomX Therapeutics, Inc. initiated the phase 2 PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 program — designed to evaluate CX-072, an anti-PD-L1 Probody , in combination with Yervoy (ipilimumab), an anti-CTLA-4 antibody, for the treatment of patients with relapsed or refractory melanoma.

The open-label, multi-center phase 2 clinical study will evaluate approximately 40 patients being enrolled into stage 1 of the study, with additional patients being enrolled into stage 2 pending the outcome of the first stage. CytomX anticipates initial data from stage 1 in 2020.

“This exciting study leverages our unique technology platform to enable a more powerful combination therapy directed against the two best validated pathways in immuno-oncology and could represent a significant advance in outcomes for these patients who have few treatment options,” Dr. Amy Peterson, chief development officer of CytomX Therapeutics, said in a press release.