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RECRUITING Phase 1

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

NCT05932862 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 429 participants
Start Date 2024-04-03
Est. Completion 2029-08-03
Phase Phase 1

Sponsor

Exelixis

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05932862

The ClinicalTrials.gov registry entry for NCT05932862 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 429 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05932862 reports 16 study locations spanning 10 distinct geographic areas — top geographies include Texas, Florida, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05932862?

The interventions under investigation include: Olaparib (DRUG), XL309 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05932862?

This trial is sponsored by Exelixis, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial