← Back to Search

Other

Oral STC-15 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by STORM Therapeutics LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age
ECOG PS of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through end of treatment, approximately 6 months
Awards & highlights

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.

Who is the study for?
Adults over 18 with advanced cancers that haven't responded to standard treatments can join this trial. They should be relatively active and have good organ function. People who've had recent major surgery, radiation, or other cancer therapies, those with autoimmune diseases needing treatment in the last 2 years, or a history of severe brain-related side effects from drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing STC-15, an oral medication for various advanced cancers. It's given in cycles every three weeks using a specific plan to increase doses safely. The study will look at how well it works and its effects on the body alongside potential use with approved cancer treatments.See study design
What are the potential side effects?
Since STC-15 is new and being tested for the first time in humans, exact side effects are unknown but may include typical reactions seen with cancer medications such as fatigue, digestive issues, blood disorders and possibly others based on how it affects the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
My advanced cancer has not responded to standard treatments, and I have no other standard options or have chosen not to pursue them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through end of treatment, approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through end of treatment, approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC (PK)
Accumulation ratio from first dose to steady-state (PK)
Average concentration (PK)
+7 more
Secondary outcome measures
Efficacy as measured by RECIST 1.1 (DCR)
Efficacy as measured by RECIST 1.1 (DoR)
Efficacy as measured by RECIST 1.1 (ORR)
+2 more
Other outcome measures
Assessment of m6A modification of mRNA from peripheral blood
Cytokine

Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Level 5Experimental Treatment1 Intervention
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Group II: Dose Level 4Experimental Treatment1 Intervention
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Group III: Dose Level 3Experimental Treatment1 Intervention
100mg capsules, MWF administration for 3 week (21 day) cycles
Group IV: Dose Level 2Experimental Treatment1 Intervention
30mg capsules, MWF administration for 3 week (21 day) cycles
Group V: Dose Level 1Experimental Treatment1 Intervention
30mg capsules, daily administration for 3 week (21 day) cycles

Find a Location

Who is running the clinical trial?

STORM Therapeutics LTDLead Sponsor
Josefin HolzStudy DirectorSTORM Therapeutics

Media Library

STC-15 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05584111 — Phase 1
Cancer Research Study Groups: Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5
Cancer Clinical Trial 2023: STC-15 Highlights & Side Effects. Trial Name: NCT05584111 — Phase 1
STC-15 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584111 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Some body tell me this can work for me and i try pls help me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Oral Administration of STC-15 in Subjects With Advanced Malignancies
2022. "Oral Administration of STC-15 in Subjects With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05584111.
~4 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top