Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
STX-478 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| [14C]-STX-478 | EXPERIMENTAL | Healthy participants will receive a single dose of \[14C\]-STX-478. |
| Dose Escalation (Advanced Solid Tumors) | EXPERIMENTAL | * Cohort A0: Advanced Solid tumors expressing PI3Kα mutations * Cohort A1: HR+ breast cancer expressing PI3Kα mutations |
| Dose Expansion | EXPERIMENTAL | * Cohort A2: Gynecologic cancers * Cohort A3: Head and Neck Squamous Cell Carcinoma * Cohorts A4/A5: Other solid tumors not included in Cohorts A1, A2, A3 expressing PI3Kα mutations * Cohort A6: Endometrial cancer * Cohort A7: Non-gastrointestinal solid tumors |
| Dose Selection/Expansion: Combination STX-478 + fulvestrant | EXPERIMENTAL | Cohort B: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Kα mutations |
| Dose Selection/Expansion Combination | EXPERIMENTAL | STX-478 + Endocrine therapy + CDK4/6 inhibitor Cohort C/D/E: HR+/HER2- or HR+/HER2low breast cancer expressing PI3Ka mutations |
| Experimental: Drug to Drug Interaction (DDI) Metformin STX-478 +/- ET ([AIs or fulvestrant] | EXPERIMENTAL | CDK4/6 inhibitor therapy in Cohort A8: all solid tumors Cohort B2 and Cohort F: HR+/HER2- or HR+/HER2 low breast cancer expressing PI3Kα mutations |
| Name | Type | Description |
|---|---|---|
| [14C]-STX-478 | DRUG | oral administration |
| STX-478 | DRUG | STX-478 is a mutant-selective PI3Kα inhibitor |
| Fulvestrant | DRUG | Fulvestrant |
| Ribociclib | DRUG | Ribociclib |
| Palbociclib | DRUG | Palbociclib |
| Letrozole | DRUG | Letrozole |
| Anastrozole | DRUG | Anastrozole |
| Exemestane | DRUG | Exemestane |
| Tamoxifen | DRUG | Tamoxifen |
| Abemaciclib | DRUG | Abemaciclib |
| Imlunestrant | DRUG | Imlunestrant |
| Metformin | DRUG | Metformin |
Inclusion Criteria: * Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening. * Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antige...
Top 20 of 92 competitors
STX-478 is an investigational small molecule being studied for the treatment of advanced solid tumors, including breast cancer. It is currently in Phase 1 clinical trials, both as a monotherapy and in combination with other antineoplastic agents. STX-478 is not yet approved by the FDA and remains in clinical development.
STX-478 targets the PIK3CA gene. It is being studied in patients with advanced solid tumors, including breast cancer. The drug is designed to interfere with the function of this gene, which is often mutated in cancer. However, the exact mechanism of action is not fully described in the available clinical trial information.
STX-478 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
STX-478 is currently in Phase 1 clinical trials. There are two Phase 1 studies: one in patients with advanced solid tumors and another in healthy male participants. The drug is investigational and has not yet received FDA approval. It is still in the early stages of clinical development.
STX-478 is being studied in two Phase 1 clinical trials. The first, NCT05768139, is a first-in-human study of STX-478 as monotherapy and in combination with other antineoplastic agents in participants with advanced solid tumors, including breast cancer. The second, NCT06901336, is a study of LY4064809 [14C]-STX-478 in healthy male participants.
STX-478 is also known as LY4064809 in some clinical trial contexts. For example, a study of LY4064809 [14C]-STX-478 in healthy participants refers to the same drug. This alternative name is used in the clinical trial registry to identify the compound.