Trial to Evaluate Safety, Efficacy of Novel Drug for Various Solid Tumors Treats First Patient

The primary focus of the trial is to evaluate the incidence of treatment-emergent and serious side effects in patients receiving either the novel drug alone or in combination with Keytruda.

The first patient has been dosed in an early-phase trial of a novel drug as either a monotherapy or in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced solid tumors, according to Immune-Onc Therapeutics, the manufacturer of the investigational therapy.

"We are very pleased to announce the initiation of our phase 1 study of IO-202 in solid tumors … ,” Dr. Paul Woodard, chief medical officer of Immune-Onc, said in the press release. “We believe by targeting the LILRB4 checkpoint, IO-202 may reverse the immunosuppressive effects of tumor-associated monocytic myeloid cells, enhance dendritic cell function and promote T cell activation — thereby, unleashing the antitumor activities of the immune system and increasing the therapeutic benefit of T-cell checkpoint inhibitors.”

The trial investigators are looking to assess the safety and tolerability of increasing doses of IO-202 either as a monotherapy or in combination with Keytruda to eventually select the recommended phase 2 dose.

The plan is to then enroll expansion cohorts onto the trial to assess the regimens across multiple tumor types. Researchers hope to enroll approximately 200 patients across both portions of the trial.

The primary focus of the trial is to evaluate the incidence of treatment-emergent and serious side effects in either treatment group, as well as the number of dose-limiting toxicities and study discontinuation due to side effects.

The investigators also plan to review the anti-tumor activity of both treatment regimens, meaning how the disease responds to either the single-agent drug or combination.

Enrolled patients must be aged 18 years or older and have confirmed advanced or metastatic solid tumor and received, been intolerant to or ineligible for standard systemic therapy. For the dose-expansion portion of the trial, a patient’s disease must have failed to respond to at least one available therapy.

Patients can be excluded from enrolling onto the trial for a multitude of reasons, including a history of interstitial lung disease, as well as congestive heart failure and a history of experiencing severe or worse side effects with any prior immunotherapy.

Immune-Onc Therapeutics noted that as part of the trial, they will explore various biomarkers to potentially allow them to better understand the data and inform future trials.

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