Clinical Trials

Are you or do you have possible candidates for our clinical trials?

We are looking for patients who suffer from metastatic renal cancer and would like to participate in a clinical trial to test a new potential treatment. The objective of the study is to evaluate the safety, tolerability, and anti-tumor efficacy of ONC175 treatment in patients with Metastatic Clear-Cell or Papillary Renal Cell Carcinoma. Find out more about the trial and check your or your candidate’s eligibility here:

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Phases of Development

Preclinical testing
An experimental therapy is first tested in the laboratory and in animal studies. After this preclinical testing, and only if shown to meet certain safety criteria and to have value as a potential new therapy, the drug candidate advances to clinical testing in humans.

Early clinical testing
In trials for new cancer treatments the initial patients included are usually advanced cancer patients. The aim for these studies is to understand safety and tolerability for the new drug. Doses and how the drug is metabolized by the patient is also studied. In addition, signs of clinical effect of the new drug are often analyzed, for example tumor shrinkage.

Pivotal trials
Pivotal clinical trials (typically Phase III) test the results of earlier trials in larger groups of patients to confirm the effectiveness and safety of the experimental therapy. These trials are often randomized, where patients will either receive the experimental therapy, placebo, or another therapy (a “comparator”), and “double-blinded,” in which neither the investigator nor the participant are aware if the therapy given is the true experimental therapy, placebo (medication with no active ingredients) or another therapy (a “comparator”). These trials are the basis for the application to register a new treatment.

Registration
Filing an application for registration with the country’s health regulatory authority is the next step in bringing a potential new treatment to patients.

Quick Facts

For Caregivers

Oncorena has completed all preclinical studies and has initiated a Phase I/II clinical trial. The clinical Phase I/II trial protocol has been developed in collaboration with Karolinska University Hospital in Stockholm, Sweden.

Oncorena has received regulatory approval by the Swedish Medical Products Agency to start the first clinical trial of ONC175 (orellanine) in patients with metastatic renal cancer at Centre for Clinical Cancer Studies at the Karolinska University Hospital in Stockholm, Sweden. The study will subsequently be expanded to other countries.

For more information and contact
If you have patients with advanced renal cancer who are on chronic dialysis and who may be eligible for inclusion in Oncorena’s clinical program, please contact clinicaltrials@oncorena.com.

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