Breast Cancer Solid Tumors, Adult
Conditions
Interventions
DRUG: STX-478(Other Name: LY4064809)
STX-478 is a mutant-selective PI3Ka inhibitor
DRUG: Fulvestrant(Other Name: Faslodex)
Fulvestrant
DRUG: Ribociclib(Other Name: Kisqali)
Ribociclib
DRUG: Palb
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 will provide an adequate tissue sample prior to screening 3. Has a tumor that harbors a documented PI3Kalpha mutation (cohort specific criterion for cohort-specific mutation types) 4. Is >=18 years of age at the time of signing the ICF 5. Has an ECOG performance status score of 0 or 1 at screening 6. Has adequate organ function as defined per protocol
Exclusion criteria
Exclusion criteria: 1. Has history (within =8% and/or FBG >=140 mg/dL [7.7 mmol/L] and/or requiring or required insulin). 4. Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances 5. Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days. Endocrine therapy does not require a washout period if the patient is enrolling in a cohort with the same combination endocrine therapy. 6. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade <=1, with the exception of alopecia and peripheral neuropathy. 7. Has had radiotherapy within 14 days before the initiation of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who experience at least 1 Dose Limiting Toxicity (DLT) [ Time Frame: First 28 days of treatment | — |
Countries
France, Italy, Japan, Spain, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed