Phase 1 Study of XL309 for Advanced Solid Tumors
This study is testing a new drug called XL309, both by itself and in combination with another drug called olaparib. It's for people with advanced solid tumors that have continued to grow despite previous treatments. The main goals are to understand how safe XL309 is, what side effects it might cause, and how much of the drug stays in your body over time. Researchers will also look for early signs that the treatment is working against cancer. You may be able to join if you are 18 or older, have a good general health status, and your tumor has progressed. The study plans to enroll up to 429 participants.
- Study design
- This is a Phase 1, first-in-human study, meaning it's one of the first times this drug is being tested in people. It is an open-label study, so both you and your doctors will know which treatment you are receiving. The study aims to enroll 429 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which measure safety and drug levels, will be assessed for approximately 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
16 sites across 10 statesWho to contact
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What this trial measures
- Dose Escalation Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory AbnormalitiesApproximately 24 months
Adverse events will be recorded and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Dose Escalation Stage: Incidence of Dose-Limiting Toxicities (DLTs)Approximately 24 months
- Dose Escalation Stage: XL309 Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC)Approximately 24 months
- Dose Escalation Stage: XL309 Maximum Plasma Concentration (Cmax)Approximately 24 months
- Dose Escalation Stage: XL309 Time to CmaxApproximately 24 months
- Dose Escalation Stage: XL309 Trough Concentration (Ctrough)Approximately 24 months
Lowest concentration of drug in the bloodstream, measured just before the next dose is administered.
- Dose Escalation Stage: XL309 Apparent Clearance (CL/F)Approximately 24 months
- Cohort Expansion Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory AbnormalitiesApproximately 24 months
Adverse events will be recorded and severity graded using CTCAE version 5.0.
- Cohort Expansion Stage: Objective Response Rate (ORR)Approximately 24 months
ORR will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the Investigator. ORR for prostate cancer will be based on Prostate Cancer Working Group 3 (PCWG3) criteria, as assessed by the Investigator