A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
← catalyst calendarNCT05932862 · readout in 868 d
Sponsored by Exelixis (industry) · EXEL — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
429estimated
Sites
16
Country
United States
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 | 2024-04-03 | actual | When the study began enrolling |
| Primary completion | 2029-01-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-08-03 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumor
Interventions
- Drug: XL309 — also filed as ISM3091
- Drug: Olaparib
Primary outcomes
what the primary-completion date above is the date OFDose Escalation Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities
measured Approximately 24 months
Dose Escalation Stage: Incidence of Dose-Limiting Toxicities (DLTs)
measured Approximately 24 months
Dose Escalation Stage: XL309 Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC)
measured Approximately 24 months
Dose Escalation Stage: XL309 Maximum Plasma Concentration (Cmax)
measured Approximately 24 months
Dose Escalation Stage: XL309 Time to Cmax
measured Approximately 24 months
Dose Escalation Stage: XL309 Trough Concentration (Ctrough)
measured Approximately 24 months
Dose Escalation Stage: XL309 Apparent Clearance (CL/F)
measured Approximately 24 months
Cohort Expansion Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities
measured Approximately 24 months
Cohort Expansion Stage: Objective Response Rate (ORR)
measured Approximately 24 months
Publications
- PMID 38885312 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · EXEL's whole pipeline · Catalyst calendar · Every registered study · What changed