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

NCT05222802 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-17

No results posted yet for this 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

Interventions

DRUG

ERAS-801

Administered orally

Sponsors & Collaborators

  • Erasca, Inc.

    collaborator INDUSTRY

  • Katmai Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Les Brail · Medical Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2025-08-31
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222802 on ClinicalTrials.gov