Trial Launches to Assess Novel Immunotherapy Approach in Metastatic Prostate Cancer

The first patient has been dosed with a novel treatment in a phase 1/2a clinical trial to assess its effectiveness in metastatic castration-resistant prostate cancer (mCRPC).

The aim of the trial is to examine LAVA-1207, a Gammabody that targets prostate-specific membrane antigen (PSMA) — a protein that fuels prostate cancer cell growth. The Gammabody platform is currently under development by LAVA Therapeutics, N.V., and it has a goal of using bispecific gamma delta T cell engagers (bsTCEs) — or artificial antibodies to direct a patient’s immune system against cancer cells — for a different approach to cancer treatment.

“Bispecific gamma delta T cell engaging therapies have the potential to bring novel immunotherapy approaches to those tumors that have not benefitted from the advancement of other immunotherapies. We are thrilled to work with LAVA and initiate a trial of LAVA-1207 for mCRPC,” said Dr. Martijn Lolkema, a medical oncologist at Erasmus MC Cancer Institute in Rotterdam, Netherlands and one of the study’s lead investigators, in a news release.

LAVA-1207 has demonstrated preclinical proof-of-concept, meaning that a biological effect predicted it would be feasible in an advanced-phase clinical trial.

The study authors predict that the Gammabody platform, which uses selective tumor cell killing, may lessen patients’ risks for on-target/off-tumor toxicity (when non-tumor cells are attacked) and cytokine release syndrome (when the cytokines overstimulate the immune system, causing it to attack healthy organs).

“Our off-the-shelf Gammabody, LAVA-1207, has preclinically demonstrated dose-dependent, potent and selective anti-cancer activity against PSMA-expressing tumors through the triggering of gamma delta T cell-mediated immunity,” said Dr. Benjamin Winograd, chief medical officer of LAVA Therapeutics.

The trial is planned to take place across the Netherlands at multiple centers, including the Erasmus MC Cancer Institute. Researchers hope to assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of LAVA-1207. In the phase 1 portion of the trial, researchers intend to examine dose-escalation to determine the correct dose for phase 2.

Although the trial has only been initiated in Europe, the plan is to expand enrollment to patients in the U.S.

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