Clinical Trial Finder
Oral Administration of STC-15 in Subjects With Advanced Malignancies
Study Purpose
This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Key
Inclusion Criteria:
- - ECOG PS of 0 or 1.
KeyExclusion Criteria:
- - Central nervous system (CNS) disease involvement, or prior history of Grade ≥3
drug-related CNS toxicity.
- Active autoimmune disease that has required systemic treatment in the 2 years prior to ScreeningTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Dose Level 1
30mg capsules, daily administration for 3 week (21 day) cycles
Experimental: Dose Level 2
30mg capsules, MWF administration for 3 week (21 day) cycles
Experimental: Dose Level 3
100mg capsules, MWF administration for 3 week (21 day) cycles
Experimental: Dose Level 4
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Experimental: Dose Level 5
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
Interventions
Drug: - STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Honor Health
Scottsdale, Arizona, 85258
Site Contact
Mei Yu
[email protected]
617-233-4057
Status
Recruiting
Address
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Site Contact
Jordi Rodon Ahnert, M.D., PhD
[email protected]
713-792-5603
Status
Recruiting
Address
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Site Contact
Isabel Jimenez
[email protected]
210-593-5265
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