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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2025-09-30

Brief Summary

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* 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.

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Detailed Description

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This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation (Part 1)

ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.

Group Type EXPERIMENTAL

ERAS-801

Intervention Type DRUG

Administered orally

Dose Expansion (Part 2)

ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR.

Group Type EXPERIMENTAL

ERAS-801

Intervention Type DRUG

Administered orally

Interventions

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ERAS-801

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Willing and able to give written informed consent
* Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria
* Adequate organ function
* Willing to comply with all protocol-required visits, assessments, and procedures
* Able to swallow oral medication

Exclusion Criteria

* Prior treatment with an EGFR inhibitor for Glioblastoma
* Currently enrolled in another therapeutic study
* History of clinically significant cardiovascular disease
* Gastrointestinal conditions that may affect administration/absorption of oral medications
* Have an active infection (bacterial, fungal, or viral) requiring systemic therapy
* Pregnant or breastfeeding women
* Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study
* Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No