Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05932862 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

NCT05932862 · ClinicalTrials.gov record · last posted 2025-09-05

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

Name: A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors — clinical trial record (NCT05932862)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1

SponsorExelixis

Started2024-04-03

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.

Amendment record 18 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 18 times since 2023-06-27; most recent amendment 2025-08-28. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-09-01

Status change Not Yet Recruiting→Recruitingv1

Trial Details

NCT Number	NCT05932862
Lead Sponsor	Exelixis
Conditions	Advanced Solid Tumor
Enrollment	429 participants
Start Date	2024-04-03
Primary Completion	2029-01-03 (estimated)
Study Completion	2029-08-03 (estimated)
Updated on ClinicalTrials.gov	2025-09-05