What is the Purpose of this Study?
The purpose of this study is to evaluate an experimental drug called STX 478 that is designed to specifically target mutated cancer cells (cancer cells that have a change in genetic structure) with mutations in a gene called PIK3CA and spare healthy cells in people who have an advanced solid tumor (cancer that has spread to other parts of the body). STX-478 may potentially kill cancer cells while reducing the amount of side effects that are usually seen with standard chemotherapy drugs. Participants will take STX-478 daily as an oral tablet either alone or in combination with other treatments. Researchers aim to identify a tolerable and accepted dose of STX-478 and determine how the body deals with the drug at different dose levels. The study will also examine the amount of STX-478 in the blood and how the body processes STX-478, in addition to assessing participants’ quality of life while taking STX-478 through questionnaires.
Eligibility
- 1. Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)
- 2. Has a new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen within 10 years prior to screening
- 3. Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types) obtained either from tumor or plasma samples, determined by PCR or NGS-based assay as an FDA-approved test in US, CE marked in EU, or obtained as part of normal clinical care in a CLIA certified or similarly certified laboratory.
- 4. Is ≥18 years of age at the time of signing the ICF
Where can I participate?
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
More about this Clinical Trial
What is the full name of this clinical trial?
STX-478-101: First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors