Clinical Trials
For over a decade, Oncomatryx has been pioneering new approaches to change the landscape of metastatic cancer treatment. Our drug, OMTX705, is currently in clinical trials targeting aggressive tumors that have no effective treatment options.
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What is an Oncology Clinical Trial?
A clinical trial in oncology is a critical step in developing new cancer treatments. Its primary goal is to evaluate the effectiveness of newly developed drugs to determine if they contribute to treating the disease and improving the well-being of participating patients.
Studies also examine the safety of new treatments, identifying any adverse reactions they may cause. Without this research, we would lack the necessary evidence to confirm the efficacy and safety of innovative therapies.
Clinical trials protect patient rights by strictly adhering to current national and international regulations, ensuring that they are ethical, necessary, and viable.
Why Should Patients Participate in Clinical Trials?
The collaboration of cancer patients in these trials is key to advancing medicine and improving public health now and in the future. Moreover, these trials offer an open door for patients who have not found a solution to their illness with currently available treatments.
Participating in a clinical trial allows cancer patients to:
● Access innovative therapies. It is a way to gain early access to innovative treatments that are not yet available otherwise.
● Receive regular and careful medical attention. It involves close monitoring by medical professionals and research teams, with additional tests to evaluate the treatment’s effectiveness.
● Contribute to the future of healthcare. While the effectiveness of the product cannot be guaranteed, it is an opportunity to foster medical advancement and global therapeutic progress.
While illnesses affect everyone equally, we understand that each person is unique and may respond differently to treatments. This is why we need diverse participation in clinical trials, regardless of your ethnic background, race, or gender.
Would you like to learn more about these trials? Find out more here.
How is an oncology trial conducted?
Before a new drug is tested in patients through a clinical trial to determine its effectiveness and safety, it must undergo laboratory and animal testing. This initial research period is known as the preclinical phase. Afterward, drugs that show promising results are selected for more rigorous evaluation in humans through clinical trials.
Only those drugs that meet the requirements at each phase can eventually be approved for market, a process that can take over a decade. Discover how a clinical trial progresses:
Phase I
Focuses on evaluating the safety of the treatment in humans, determining the most effective way to administer it and the optimal doses. This phase involves a small number of participants and can be applied to various types of cancer, allowing researchers to gather preliminary data on how the body responds to the drug.
Phase II
Aims to investigate the drug’s effectiveness and confirm its safety in a larger group of patients than in Phase I, all selected based on having the same type of cancer.
Phase III
Confirms the therapeutic benefits and safety of the new treatment or combination of treatments in a larger, well-defined group of patients.
Phase IV
After the drug has been released to the market. The goal is to collect additional data on the drug’s safety and effectiveness, observing its effects in a significantly larger population.
Clinical trials are meticulously designed to test specific interventions on particular types of tumors, which requires that only patients meeting detailed criteria can participate. This approach ensures that study results are applicable and relevant to the conditions under investigation.
You can find more information about the OMTX705 clinical trial here:
https://clinicaltrials.gov/study/NCT05547321?term=oncomatryx&rank=1
¿Se utiliza placebo en los ensayos ocológicos?
Al participar en un ensayo clínico de Fase III, y en muchos casos de Fase II, los pacientes se integran en dos grupos principales de tratamiento: un grupo de estudio, compuesto por aquellos que recibirán el tratamiento en investigación; y un grupo control, compuesto por los que tomarán el tratamiento convencional.
En raras ocasiones, los pacientes pueden recibir un placebo, y la asignación a uno u otro grupo se realiza aleatoriamente, garantizando así que las características individuales de los pacientes no sesguen los resultados del estudio. En algunos casos, los pacientes desconocen inicialmente qué tratamiento están recibiendo, ya sea el experimental o el convencional, y sólo se revela al final del ensayo.
Esta metodología, aunque compleja en apariencia, tiene como objetivo primordial asegurar que los resultados del nuevo tratamiento sean atribuibles únicamente a sus propiedades medicinales, excluyendo cualquier otro factor que pueda influir negativamente en la interpretación de los datos.
Researchers
If you are an oncologist and/or researcher interested in learning more about the development of our trials, please get in touch with us.
You can find more information about the OMTX705 clinical trial here:
https://clinicaltrials.gov/study/NCT05547321?term=oncomatryx&rank=1
Nuestros estudios clínicos se centran en el tratamiento del cáncer desde la fase 1, lo que implica que abordamos a pacientes con esta enfermedad desde el principio. Actualmente, llevamos a cabo un ensayo clínico llamado OMTX 705, en la etapa de escalado de dosis, tanto en monoterapia como en combinación, con el objetivo de finalizar a finales de 2024.
Este ensayo cuenta con la aprobación tanto de la Agencia Española del Medicamento como de la FDA de Estados Unidos. La información oficial sobre el ensayo está disponible a través del Registro Español de Ensayos Clínicos y también en la FDA.
Así, nuestra estrategia terapéutica va más allá, centrándose en el desarrollo de conjugados anticuerpo-fármaco destinados a proteínas específicas presentes en el microentorno tumoral.
Esta innovadora vía de tratamiento apunta a las células estromales que facilitan la invasión, suprimen la respuesta inmune y promueven la resistencia a los fármacos, abriendo de esta forma nuevas posibilidades en la batalla contra el cáncer en el microentorno tumoral.
