All > Recurrent Glioblastoma > Glioblastoma Multiforme

ST101 for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute, Nashville, TNGlioblastoma+13 MoreST101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Advanced Solid Tumors
  • Glioblastoma
  • Metastatic Melanoma
  • Prostate Cancer
  • Cancer Brain Metastases
  • Metastatic Breast Cancer
  • Glioblastoma (GBM)
  • Glioblastoma Multiforme
  • Breast Cancer
  • Hormone-Refractory Prostate Cancer
  • Recurrent Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Posaconazole Pill
1
AZD1390
1
Combination Drug Therapy

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 30 Months

20 Months
DCR
20 months
Adverse Events
Cmax
Dose-Limiting Toxicity (DLT)
Duration of Response
Overall Response
PFS
Terminal Half-Life (t1/2)
30 Months
Area Under the Curve (AUC)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Posaconazole Pill
1
AZD1390
1
Combination Drug Therapy

Trial Design

7 Treatment Groups

Dose Expansion HR+ Breast
1 of 7
Dose Expansion CRPC
1 of 7
Dose Expansion Recurrent Glioblastoma
1 of 7
Newly Diagnosed Glioblastoma
1 of 7
Dose Expansion Melanoma
1 of 7
Dose Expansion GBM
1 of 7
Dose Escalation
1 of 7

Experimental Treatment

162 Total Participants · 7 Treatment Groups

Primary Treatment: ST101 · No Placebo Group · Phase 1 & 2

Dose Expansion HR+ Breast
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Dose Expansion CRPC
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Dose Expansion Recurrent Glioblastoma
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Newly Diagnosed Glioblastoma
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Dose Expansion Melanoma
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Dose Expansion GBM
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Dose Escalation
Drug
Experimental Group · 1 Intervention: ST101 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ST-101
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months

Who is running the clinical trial?

Sapience TherapeuticsLead Sponsor
Yasser Kamel, MDStudy DirectorSapience Medical Monitor
Alice Bexon, MDStudy ChairCMO
5 Previous Clinical Trials
329 Total Patients Enrolled
Abi Vainstein-Haras, MDStudy DirectorSapience Medical Monitor

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumor that cannot be removed by surgery and is either melanoma, carcinoma, sarcoma, HR positive LA/MBC, GBM, or CRPC. You agree to undergo a biopsy before starting the treatment and another one during the treatment. The tissue samples for biopsy should be newly obtained and not previously exposed to radiation. If you have GBM, previously collected tissue samples can be used.
The study is looking for patients who have not responded well to or cannot receive standard treatment options. Patients who have had up to three previous lines of treatment may be eligible for the dose escalation phase. For the expansion phase, patients with specific types of cancer must have progressed after one or two previous treatments. For example, patients with hormone receptor-positive breast cancer must have progressed after one or two hormone-based therapies. Patients with prostate cancer must have progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide, or cannot tolerate these treatments.
References

Frequently Asked Questions

How many participants have joined this research endeavor?

"This clinical trial requires 162 participants who possess the specified inclusion criteria. Those interested in joining this medical research can visit Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, Texas and Northwestern Medicine Cancer Centers in Warrenville, Illinois for enrollment." - Anonymous Online Contributor

Unverified Answer

Does this experiment bring anything new to the scientific community?

"Since 2020, ST101 has been under investigative scrutiny. Sapience Therapeutics sponsored the first study of 162 participants and then followed it up with successful Phase 1 & 2 drug approvals. Currently, there is one active trial for this product ran by Sapience Therapeutics." - Anonymous Online Contributor

Unverified Answer

Has ST101 been subject to any other scientific investigations?

"The first instance of research on ST101 was conducted in 2020 by the University of Leeds. To date, there are 3 concluded studies and 1 still ongoing clinical trial based mostly out of Dallas, Texas." - Anonymous Online Contributor

Unverified Answer

What are the projected outcomes of this investigation?

"This 20-month trial's primary objective is to measure Dose-Limiting Toxicity (DLT). Secondary objectives encompass Area Under the Curve (AUC), Duration of Response, and Cmax." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available in this research venture?

"Affirmative. The clinical trial is accepting volunteers as per the data available on clinicaltrials.gov. It was originally listed in July of 2020, with updates made up until November 15th 2022; 162 individuals will be recruited from 8 different medical institutions." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are administering this clinical trial?

"Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, Texas, Northwestern Medicine Cancer Centers in Warrenville, Illinois and Columbia University in New York City are amongst the 8 additional medical centres involved with this test." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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