CB-03-10 for Advanced Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CB-03-10 (Cortexolone 17α-valerate-21-propionate) for individuals with advanced cancers unresponsive to other treatments. The goal is to determine the optimal dose while assessing the treatment's effects on the body and cancer. Participants will begin with varying doses to identify the most effective one, after which they will receive this optimal dose. This trial suits those with advanced solid tumors who have tried other treatments without success and can manage everyday activities with some effort. Regular check-ups will monitor the treatment's effectiveness. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you should not have had anticancer therapy within 28 days before starting the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that CB-03-10 is likely to be safe for humans?
Research has shown that CB-03-10 is being tested for safety in humans, particularly for treating advanced cancers. Currently, the treatment is in the early testing phase, where researchers determine safe dosage levels.
There is limited safety data from humans so far. However, tests in lab animals, such as mice, have been conducted to observe its effects. These studies suggest it might help fight tumors, but this does not directly prove its safety for humans.
In this early-stage trial, researchers are determining the best dose and observing how people respond. Early trials like this one aim to identify any side effects and ensure the treatment is tolerated at different doses.
As the trial progresses, more safety information will become available. For now, the focus remains on careful monitoring and adjusting doses to minimize any negative effects.12345Why do researchers think this study treatment might be promising?
CB-03-10 is unique because it offers a fresh approach to treating advanced cancers with its innovative mechanism of action. Unlike traditional treatments that often target cancer cells broadly, CB-03-10 works by specifically interfering with a key pathway in cancer cell growth, potentially leading to more targeted and effective outcomes with fewer side effects. Researchers are particularly excited about its ability to precisely disrupt cancer cell proliferation, which could make it a promising option for patients who haven't responded well to existing therapies.
What evidence suggests that CB-03-10 might be an effective treatment for advanced cancers?
Research shows that CB-03-10, the investigational treatment in this trial, might help treat some advanced cancers. In lab studies, CB-03-10 has demonstrated the ability to fight tumors, particularly in prostate cancer. It sometimes enhances the response of prostate cancer cells to other treatments. Studies on breast and ovarian cancer cells also suggest that CB-03-10 could work well with other cancer drugs. Although these results are promising, most evidence comes from lab and animal studies. More research with people is needed to determine how well CB-03-10 works for advanced cancers.12367
Are You a Good Fit for This Trial?
Adults over 18 with advanced solid tumors that can't be treated with standard therapy may join. They must have a performance status indicating they're still fairly active, proper organ function, and for women of childbearing age, a negative pregnancy test and use of birth control. People are excluded if they have autoimmune diseases, serious heart issues, uncontrolled high blood pressure, recent major surgery or radiation, recent other cancer treatments, hepatitis B/C or HIV infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Subjects receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints.
Dose Expansion
Subjects receive CB-03-10 at the RP2D determined in Part 1 of the study. Indications included in each group will be determined by the Safety Review Committee.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response will be re-evaluated at least 4 weeks later for confirmation.
What Are the Treatments Tested in This Trial?
Interventions
- CB-03-10
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cosmo Technologies Ltd
Lead Sponsor