CURE’s Clinical Trial Corner: January 2021

As the cancer treatment landscape continues to expand, patients and their caregivers should be aware of the various clinical trials currently being conducted — including studies they can possibly join.

Small Cell Lung Cancer

The first patient has been dosed in an ongoing phase 1/2 trial of HPN328, an investigational therapy, for the treatment of patients with small cell lung cancer and other tumors associated with expression of delta like ligand 3, a protein highly expressed in certain tumors.

“Treatment options for small cell lung cancer are limited, as are options for other DLL3-associated tumors such as neuroendocrine prostate cancer,” Harpoon Therapeutics’ chief medical officer Dr. Natalie Stacks said in a company-issued press release. “Data from preclinical studies suggest that HPN328 has substantial anti-tumor activity, which provides the rationale for investigating its potential benefit in these patients.”

The aim of the open-label study is to assess the safety, tolerability and pharmacokinetics (how a drug is absorbed and released from the body) of HPN328. Patients with small cell lung cancer whose disease has relapsed after received at least one prior line of platinum-based chemotherapy are expected to be enrolled in the study.

“We are excited to participate in this trial of a promising agent that will hopefully benefit patients with small cell lung cancer and other neuroendocrine tumors,” Dr. Melissa Johnson, program director of lung cancer research at Sarah Cannon Research Institute, said in the release.

The first patient was treated at Sarah Cannon Research Institute at Tennessee Oncology.

Brain Cancer

Kintara Therapeutics recently announced that patient recruitment for a registrational phase 2/3 clinical trial for glioblastoma has begun.

The goal of the trial – Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) – is to evaluate the safety and efficacy of VAL-083 in those with recurrent or newly-diagnosed glioblastoma.

"The entire Kintara team is grateful and excited to participate in (Global Coalition for Adaptive Research)'s groundbreaking GBM AGILE study as it offers an extraordinary opportunity to facilitate the advancement of VAL-083's clinical development in a premier (glioblastoma) study," Kintara’s CEO Saiid Zarrabian said in a press release. "This is truly an important milestone for Kintara as we believe the study will generate important insights into the breadth of VAL-083's potential to address this deadliest form of brain cancer in all patient subtypes, while potentially bringing the program to the doorstep of commercialization."

Ovarian Cancer

The first patient has been dosed in the dose-expansion cohort of a phase 1 trial of STRO-002 for the treatment of patients with ovarian cancer, according to the agent’s manufacturer, Sutro Biopharma.

"STRO-002 continues to be well-tolerated and we have observed encouraging preliminary activity in patients with advanced platinum-resistant and refractory ovarian cancer,” Dr. Lainie Martin, leader of the gynecology/oncology program at Hospital of the University of Pennsylvania, said in a company-issued press release. “We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options."

The cohort currently enrolling includes patients with ovarian cancer with platinum-resistant disease who have previously received from one to three therapies, or platinum-sensitive patients who have received two to three previous treatments.

Uveal Melanoma

IDEAYA Biosciences recently announced the first patient was dosed in a phase 1 combination study of IDE196 and Xalkori (crizotinib) in metastatic uveal melanoma (a rare form of eye cancer).

"IDEAYA's clinical trials evaluating IDE196 plus either (Xalkori) or (Mektovi) as combination therapies are each based on compelling biological rationale for treating patients with metastatic uveal melanoma – a solid tumor for which there is a high unmet medical need and currently no approved therapies,” said Dr. Meredith McKean, associate director of the Melanoma and Skin Cancer Research Program at Sarah Cannon Research Institute at Tennessee Oncology, in a company-issued press release.

In this study, IDEAYA is collaborating with Pfizer (the manufacturer of Xalkori) in an attempt to evaluate the combination.