Clinical Research Directory

Evaluation of LB-208 (HTR1B Antagonist) in Adult Patients With Relapsed or Refractory Solid Tumours and Lymphoma

Sponsor: Leukos Biotech S.L.

Summary

This clinical study is investigating a new experimental medicine called LB-208, developed for the treatment of advanced solid tumors and lymphomas in adult patients whose disease has relapsed, not responded to treatment, or for whom no suitable standard treatment option remains. This is a Phase I trial, meaning it is an early-stage study in humans. At this stage, the main goal is not yet to prove definitive effectiveness, but rather to better understand the safety of the medicine, how it behaves in the body, and what dose may be most appropriate for future studies. LB-208 is an oral compound that works by blocking a target called HTR1B. According to the protocol, it is considered a first-in-class treatment, meaning it belongs to a new therapeutic category and has a novel mechanism of action in this setting. The drug is given orally, once a day, under fasting conditions, in continuous 28-day cycles, with no breaks between cycles. The study is open-label and uses a dose-escalation design. This means that both the medical team and the patients know which treatment is being given, and that the first groups of patients receive lower doses, which are gradually increased if tolerance is acceptable. The design used is the well-known 3+3 model: initially, 3 patients are treated at a given dose level. If no major safety concerns are seen, the dose is increased for the next group. If significant side effects appear, more patients may be enrolled at the same dose level or the escalation strategy may be adjusted. This approach helps identify the maximum tolerated dose and the recommended dose for future studies. The main objective of the trial is to assess the safety and tolerability of LB-208 and determine the dose that can be recommended for further clinical development. To do this, researchers closely monitor adverse events, laboratory test results, physical examinations, vital signs, electrocardiograms, and other clinical parameters. A particularly important part of the study is the identification of dose-limiting toxicities (DLTs), which are significant side effects occurring during the first treatment cycle and help define whether a dose is tolerable. In addition to safety, the study also examines pharmacokinetics, meaning how the medicine is absorbed, distributed, metabolized, and eliminated by the body. Blood samples are collected at different time points to measure how much LB-208 is present in the bloodstream and for how long. This information is essential to understand how the treatment works in practice and to help optimize dosing. The study also includes pharmacodynamic and exploratory biomarker analyses. These assessments aim to better understand whether the medicine is having the expected biological effect and whether there are tumor or blood markers that may help identify patients more likely to benefit from treatment in future studies. Although this early trial is not primarily designed to prove anti-tumor efficacy, researchers will also evaluate preliminary signs of clinical activity, such as tumor shrinkage, disease stabilization, duration of response, and progression-free survival. Patients taking part in the study must meet a series of eligibility criteria. In general, they must be adults with advanced cancer for which standard options are no longer effective or appropriate, have a good enough general condition to undergo experimental treatment, and meet the required organ function and laboratory parameters. As in all clinical trials, there are also exclusion criteria intended to protect patient safety, such as certain uncontrolled medical conditions, specific previous treatments, or other factors that could interfere with interpretation of the results. Participation in this trial may offer some patients access to an innovative therapy that is not otherwise available. However, because it is a Phase I study, there are also important uncertainties. The benefits cannot be guaranteed, the most appropriate dose is still being defined, and unexpected side effects may occur. For this reason, patients are followed very closely by the clinical team throughout the study. Overall, LB-208 / SERONCO-1 is an early clinical study designed to determine whether this new oral HTR1B inhibitor can be administered safely, to define the best dose for future development, and to generate the first clinical information on its potential role in treating advanced cancer. The knowledge gained from this study may help guide the next stages of development and determine whether LB-208 should move forward into later-phase trials.

Official title: Phase I, first-in Human, Open-label, Dose Escalation and Cohort Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Antitumour Activity of LB-208 (HTR1B Antagonist) in Adult Patients With Relapsed or Refractory Solid Tumours and Lymphoma

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