The first patient has been dosed in the clinical trial of peluntamig (PT217) in combination with chemotherapy, according to the drug’s manufacturer, Phanes Therapeutics. The drug is being developed for the treatment of small cell lung cancer and neuroendocrine carcinoma, including neuroendocrine prostate cancer.
The multi-center, first-in-human, open-label, phase 2/3 SKYBRIDGE study is investigating the safety, tolerability, pharmacokinetics and initial efficacy of peluntamig in patients with advanced or refractory cancers expressing DLL3. Additionally, a phase 1 trial of peluntamig is being conducted in China. The study plans to enroll and estimated 203 patients as submitted in 2024.
Furthermore, as per the release, peluntamig received two orphan drug designations from the Food and Drug Administration (FDA) for small cell lung cancer and neuroendocrine carcinoma. The agency also granted two fast track designations for extensive-stage small cell lung cancer following platinum chemotherapy with or without a checkpoint inhibitor and for metastatic de novo or treatment-emergent neuroendocrine prostate cancer. Last year, Phanes entered a clinical supply agreement with Roche to evaluate peluntamig in combination with the anti-PD-L1 therapy Tecentriq (atezolizumab).
Orphan drug designation is granted by the FDA to drugs or biological products intended to prevent, diagnose or treat rare diseases, providing incentives like tax credits, user fee exemptions and potential market exclusivity, as per the FDA.
The FDA also defines fast track designation as the process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Small cell lung cancer is an aggressive, fast-growing cancer that begins in the lung tissues and can spread to other parts of the body, as per the National Cancer Institute’s website. The cancer cells appear small and oval-shaped under a microscope.
The website also defines the bispecific antibody peluntamig which targets DLL3 and CD47 to help the immune system attack cancer cells. By blocking CD47, it allows the body’s immune cells to recognize and destroy tumors.
Patients with measurable disease by RECIST v1.1, an ECOG performance status of 0 or 1, adequate organ function, resolved side effects from prior therapies and a life expectancy of at least three months are eligible for the SKYBRIDGE trial. Those who are pregnant or lactating, have autoimmune disease, a concurrent malignancy or uncontrolled hypertension are excluded.
The study includes dose-escalation and dose-expansion phases. The dose-escalation phase determines the recommended phase 2 dose (RP2D), while the dose-expansion phase evaluates two cohorts: one receiving the RP2D and another at a lower dose level.
Primary end goals will assess dose-limiting toxicities, the maximum tolerated dose, the RP2D and safety. Secondary end goals will measure preliminary efficacy and pharmacokinetics, with disease control rate as an exploratory end goal.
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