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Study Summary
This trial will test a new drug to study safety/tolerability, how it works in body, and if it can treat advanced cancer. It may be combined with existing treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had major surgery or radiation in the last 3 weeks.I am 18 years old or older.I am fully active or can carry out light work.My advanced cancer has not responded to standard treatments, and I have no other standard options or have chosen not to pursue them.I have had severe brain-related side effects from drugs or have brain involvement in my disease.My organs and bone marrow are working well.I have been treated for an autoimmune disease in the last 2 years.I haven't had cancer treatment in the last 3 weeks.I stopped immunotherapy permanently due to severe side effects.
- Group 1: Dose Level 1
- Group 2: Dose Level 2
- Group 3: Dose Level 3
- Group 4: Dose Level 4
- Group 5: Dose Level 5
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the ultimate goal of this medical investigation?
"STORM Therapeutics LTD, the clinical trial sponsor, reports that the primary outcome assessed over a Screening through Cycle 2 (each cycle is 21 days) interval will be Adverse Events Occurrence. Moreover, efficacy as measured by RECIST 1.1 criteria such as Disease Control Rate (DCR), Duration of Response (DoR), and Progression-Free Survival/Immune-Related PFS (PFS/iPFS) will also be taken into consideration when evaluating results."
Has Dose Level 1 been sanctioned by the FDA?
"Dose Level 1's safety was assumed to be low and given a score of one due to the lack of evidence from Phase 1 trials."
Are there still open spots to join this clinical experiment?
"Affirmative; the information on clinicaltrials.gov verifies that this medical experiment is actively seeking participants. It was initially advertised on October 15th 2022, and updated most recently on October 14th 2022. The trial requires 66 volunteers from 1 site to complete it successfully."
How many individuals are partaking in this research project?
"Affirmative. Clinicaltrials.gov verifies that this analysis, newly posted on October 15th 2022, is still recruiting participants from 1 medical center with the goal of enrolling 66 patients in total."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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