A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT05932862. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05932862
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 429 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2024
- Primary completion
- Jan 2, 2029
- Completion
- Aug 2, 2029
- Last update posted
- Sep 4, 2025
2024 – 2029
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Exelixis Clinical Site #12 | Fountain Valley | California | 92708 | Withdrawn |
| Exelixis Clinical Site #15 | Jacksonville | Florida | 32224 | Recruiting |
| Exelixis Clinical Site #8 | Orlando | Florida | 32827 | Recruiting |
| Exelixis Clinical Site #16 | Tampa | Florida | 33612 | Recruiting |
| Exelixis Clinical Site #14 | Rochester | Minnesota | 55905 | Recruiting |
| Exelixis Clinical Site #10 | Kansas City | Missouri | 64111 | Withdrawn |
| Exelixis Clinical Site #9 | New Brunswick | New Jersey | 08901 | Recruiting |
| Exelixis Clinical Site #5 | New York | New York | 10029 | Recruiting |
| Exelixis Clinical Site #7 | Cleveland | Ohio | 44106 | Recruiting |
| Exelixis Clinical Site #13 | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Exelixis Clinical Site #11 | Germantown | Tennessee | 38138 | Recruiting |
| Exelixis Clinical Site #6 | Nashville | Tennessee | 37203 | Recruiting |
| Exelixis Clinical Site #4 | Austin | Texas | 78758 | Recruiting |
| Exelixis Clinical Site #1 | Houston | Texas | 77030 | Recruiting |
| Exelixis Clinical Site #2 | Houston | Texas | 77030 | Withdrawn |
| Exelixis Clinical Site #3 | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05932862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2025 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05932862 live on ClinicalTrials.gov.