What Patients Need to Know About Clinical Trials Or Patient Clinical Trial Info
Enrolling in a clinical trial is a very personal choice made by you the patient, your family and your physician. There is no right or wrong choice. On this page, we have outlined information about the trial so you and your doctor can make the most informed decision based on your specific needs and the specific tumor type with which you’ve been diagnosed.
About: This is a Phase 1 trial (IND Number 19222) to evaluate the safety and tolerability of CRX100 in adult men and women with solid tumors that are either resistant to current standard of care or are progressing.
The trial will also evaluate efficacy as a secondary endpoint.
BioEclipse believes CRX100 has the potential to address multiple cancers, and this trial targets these six specific tumor types:
- Triple negative adenocarcinoma of the breast;
- Adenocarcinoma of the colon or rectum;
- Hepatocellular carcinoma;
- Epithelial ovarian cancer; and
- Gastric cancer
Trial size: The trial will enroll 24 patients.
Dose administration: Each enrolled patient will receive up to two doses of CRX100. Enrollment will continue for a six-month evaluation period post-drug administration.
Trial sites: Two trial site will be selected.
More information is available at www.clinicaltrials.gov.
The mission of BioEclipse is to be patient focused and develop a new generation of therapies that brings hope to patients with advanced cancer who have few treatment options. We believe defeating cancer requires a drug that uses multiple mechanisms of action, working together to target and kill cancer cells all over the body, and at the same time, triggers a durable immune response that protects the patient from relapse and recurrence of disease. CRX100 addresses this need by pairing the tumor-locating ability of supercharged immune cells known as cytokine-induced killer (CIK) cells with the power of an adapted oncolytic virus into a single compound. As individual therapies, these two agents are well tested in humans and have demonstrated strong safety profiles, but shortcomings have been reported that have hobbled their efficacy as cancer treatments. We believe, based on preclinical trial results, that combining these two agents creates a differentiated drug capable of overcoming these therapeutic limitations.
Formal Trial Title: A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors
IND Number: 19222
The trial’s primary endpoint is to evaluate the frequency of adverse events related to the therapy or dosing limiting toxicities over a 28-day span following intravenous administration of up to two doses of CRX100.
Secondary endpoints include biodistribution and immune response over a 28-day timespan following administration of up to two doses of CRX100 and the early anti-tumor activity of CRX100 for a six-month span after administration of up to two doses of CRX100.
Healthcare providers at the clinical trial sites will screen and evaluate patients to determine if they meet the trial’s inclusion criteria, which can be found at ww.clinicaltrials.gov. Enrolled subjects will undergo a laboratory procedure known as leukapheresis to harvest immune cells from their blood. The cells then undergo a process in the laboratory to generate autologous cytokine induced killer (CIK) cells that are then combined with an adapted oncolytic virus. The compound is then administered to the patient intravenously.
[Coming soon – a List of Clinical Trial Sites]
Patients will be screened and evaluated to determine if they meet the trial’s inclusion criteria, which can be found at ww.clinicaltrials.gov. To be considered for the trial, a patient must be age 18 or older and able to provide documentation of the diagnosis with the original pathology report, or a recent biopsy.
Each clinical trial site is autonomous and responsible for patient recruitment and enrollment in accordance with the study’s established, and FDA allowed, inclusion criteria. Information on enrollment opportunities at a specific trial site is generally available on that facilities’ web site.
[Coming soon – scientific publications]
Designed using proprietary technology exclusively licensed from Stanford University, CRX100 combines supercharged immune cells known as cytokine-induced killer (CIK) cells with an adapted oncolytic virus to create a multimodal therapeutic approach. This means CRX100 attacks cancer cells on multiple fronts. First, delivered intravenously, the CIK cells protect the virus from attack by the body’s immune system and deliver it to malignant cells and tumors throughout the body. Next, the oncolytic virus and CIK cells work in tandem to attack and eradicate malignant cells without harming healthy tissue. Finally, CRX100 therapy is designed to trigger an immune response against the patient’s tumor cells that can potentially limit the growth of new disease and halt progression.
Frequently Asked Questions
Q: What is an open label dose-escalation trial?
A: An open label trial is an unblinded trial with no placebo arm. This means that all patients receive the study drug, with the primary goal to determine that the drug is safe in humans that its side effects are manageable or that severe side effects are rare. Phase I trials normally include dose escalation in which the amount of the drug administered to participants is periodically increased to determine the best and safest dose.
Q: What is the purpose of a Phase 1 clinical trial?
A: A Phase 1 clinical trial is primarily intended to establish safety, tolerability and dosing parameters, though early efficacy can be a secondary endpoint.
Even though a drug has been cleared by the FDA to advance into clinical trials, there is no guarantee that it will work in humans. It is important to know that efficacy can only be established when a trial is statistically significant in size. This means that the number of patients in the trial is large enough to establish that the results, positive or negative, are reflective of the drug under investigation, and did not occur by chance. Phase 1 trials are generally too small to establish statistical significance, even if efficacy were included as a secondary trial endpoint.
Q: Why did BioEclipse choose resistant and recurrent solid tumors as the target for its first clinical trial of CRX100?
A: Our decision was based on two factors. First, resistant and recurrent solid tumors represent a high unmet need in cancer treatment where patients have few available treatment options. And secondly, we believe that this is the best way to demonstrate the CRX100’s mechanism of action.
Q: Why are so few patients being enrolled in the trial?
A: Generally, a Phase 1 clinical trial will enroll anywhere from 20 to 100 patients. It is the first time a drug candidate is administered in humans with the primary purpose being to establish that the treatment is safe and to look at potential side effects that patients may experience when taking the drug. We also need to evaluate how much drug we can safely administer, known as a dose-range assessment. Establishing these initial parameters does not require a large number of patients, so a Phase 1 trial is usually limited to a small group of participants.
Q: When will patient enrollment begin?
A: Our Investigational New Drug application (IND) was cleared by the FDA in April 2020 and we are currently establishing the protocols for patient recruitment, onboarding trial sites and physicians, and laying the groundwork for a successful Phase 1 trial. BioEclipse plans to issue a press release announcing the start of patient enrollment..
Q: When is the trial expected to be completed?
A: Trial completion is highly dependent on how long it will take to enroll patients. This trial will enroll 24 patients and the active time for each participant is six months after dosing with up to two doses of CRX100. We will report data after the trial’s completion.
Q: How do I enroll in this trial?
A: BioEclipse is the trial sponsor. The individual trial sites will manage patient recruitment and enrollment based upon established inclusion criteria. Complete information about these criteria can be found on the FDA website, ww.clinicaltrials.gov.
Q: What are adverse events and dose limiting toxicities?
A: An adverse event (AE) is any harmful medical occurrence in a clinical trial participant administered a pharmaceutical product that may or may not have a causal relationship with this treatment. Treatment-related adverse events are generally classified as “mild,” “moderate” and “severe” and ranked by frequency. The goal is to ensure that patients and their physicians understand what could occur during a patient’s course of treatment and how likely it is that it will occur.
A dose limiting toxicity is a side effect that is so severe it prevents the administration of that drug at a given dose or higher. This is a critical parameter to establish, especially in the treatment of cancers that frequently require high dosing levels to maximize efficacy.
Q: Where can I find more information about the trial?
A: For more information about the trial design and protocols visit ww.clinicaltrials.gov.