First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
← catalyst calendarNCT05768139 · readout ≤ 1,441 d
Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
880estimated
Sites
65
Countries
Belgium, France, Germany +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-17 | actual | When the study began enrolling |
| Primary completion | Jul 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Cancer
- Solid Tumors, Adult
Interventions
- Drug: STX-478 — also filed as LY4064809, Tersolisib
- Drug: Fulvestrant — also filed as Faslodex
- Drug: Ribociclib — also filed as Kisqali
- Drug: Palbociclib — also filed as Ibrance
- Drug: Letrozole — also filed as Femara
- Drug: Anastrozole — also filed as Arimidex
- Drug: Exemestane — also filed as Aromasin
- Drug: Tamoxifen — also filed as Nolvadex, Soltamox
- Drug: Abemaciclib — also filed as Verzenio
- Drug: Imlunestrant — also filed as Inluriyo
- Drug: Metformin
Primary outcomes
what the primary-completion date above is the date OFNumber of participants who experience at least 1 Dose Limiting Toxicity (DLT)
measured First 28 days of treatment
Proportion of participants who experience at least 1 DLT during the first 28 days of treatment
measured First 28 days of treatment
Objective response rate (ORR) defined as the percentage of participants with partial response or complete response based on RECIST 1.1
measured 12 months
Incidence of TEAEs/SAEs ≥ grade 2
measured 12 months
Frequency of TEAEs according to CTCAE v5.0 criteria
measured 12 months
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