Trials / Recruiting
RecruitingNCT05932862
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 429 (estimated)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XL309 | XL309 will be administered orally per assigned schedule. |
| DRUG | Olaparib | Olaparib will be administered orally per assigned schedule. |
Timeline
- Start date
- 2024-04-03
- Primary completion
- 2029-01-03
- Completion
- 2029-08-03
- First posted
- 2023-07-06
- Last updated
- 2025-09-05
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05932862. Inclusion in this directory is not an endorsement.