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NCT05932862 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumor, sponsored by Exelixis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 429
- Enrollment target
- 16
- Study locations
NCT05932862: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by Exelixis.
NCT05932862 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Exelixis. The registered enrollment target is 429 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (125% higher). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05932862, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Exelixis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 429 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Primary Outcome
Adverse events will be recorded and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG XL309
Study Locations (16)
Texas
- Exelixis Clinical Site #4 - Austin
- Exelixis Clinical Site #1 - Houston
- Exelixis Clinical Site #2 - Houston
- Exelixis Clinical Site #3 - San Antonio
Florida
- Exelixis Clinical Site #15 - Jacksonville
- Exelixis Clinical Site #8 - Orlando
- Exelixis Clinical Site #16 - Tampa
Tennessee
- Exelixis Clinical Site #11 - Germantown
- Exelixis Clinical Site #6 - Nashville
California
- Exelixis Clinical Site #12 - Fountain Valley
Minnesota
- Exelixis Clinical Site #14 - Rochester
Missouri
- Exelixis Clinical Site #10 - Kansas City
New Jersey
- Exelixis Clinical Site #9 - New Brunswick
New York
- Exelixis Clinical Site #5 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2029-08-03 |
| Phase | Phase 1 |
What NCT05932862 shows while recruiting
NCT05932862 is an interventional study that assigns participants to a tested intervention. The registered 429 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (125% higher).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT05932862 lists 16 locations in 10 states (Texas, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05932862 about?
NCT05932862 is a clinical study titled "A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors". 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 a...
What is the current status of trial NCT05932862?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 429 participants. The study started on 2024-04-03. Estimated completion is 2029-08-03.
What conditions does trial NCT05932862 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT05932862?
The interventions under investigation include: Olaparib (DRUG), XL309 (DRUG).
Who is sponsoring clinical trial NCT05932862?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05932862 being conducted?
This trial has 16 study locations across California, Florida, Minnesota, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05932862's enrollment target sits among peer trials
429 16th of 189 higher than 174 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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