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ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

NCT05222802 · View on ClinicalTrials.gov ↗

Study Summary

* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801. * To evaluate the antitumor activity of ERAS-801. * To evaluate the PK profile of ERAS-801.

Conditions Studied

Interventions

  • DRUG ERAS-801

Study Locations (8)

California

  • University of California, Los Angeles — Los Angeles

Florida

  • Miami Cancer Institute-Baptist Heath South Florida — Miami

Massachusetts

  • Dana Farber Cancer Institute — Boston

Michigan

  • Henry Ford Health System — Detroit

New York

  • Memorial Sloan Kettering Cancer Center — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland

Tennessee

  • Sarah Cannon Research Institute (Tennessee Oncology) — Nashville

Utah

  • Huntsman Cancer Institute — Salt Lake City

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2022-02-25
Est. Completion 2025-09-30
Phase Phase 1

Sponsor

Katmai Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05222802

The ClinicalTrials.gov registry entry for NCT05222802 describes a study currently listed as active not 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 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Katmai Pharmaceuticals, which has 1 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 Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention — of which ERAS-801 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: NCT05222802 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Massachusetts. 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 NCT05222802 about?

NCT05222802 is a clinical study titled "A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)". * To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801. * To evaluate the antitumor activity of ERAS-801. * To evaluate the ...

What is the current status of trial NCT05222802?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2022-02-25. Estimated completion is 2025-09-30.

What conditions does trial NCT05222802 study?

This clinical trial studies the following conditions: Glioblastoma Multiforme. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05222802?

The interventions under investigation include: ERAS-801 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05222802?

This trial is sponsored by Katmai Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05222802 being conducted?

This trial has 8 study locations across California, Florida, Massachusetts, Michigan, New York. 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