Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
- * Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
- * At least 1 measurable lesion or evaluable disease per RECIST v1.1.
- * An ECOG performance status score of 0 or 1.
- * Adequate organ function.
- * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
- * Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- * Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
- * Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
- * Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
- * Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No