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

Erasca

Status and phase

Active, not recruiting

Phase 1

Conditions

Glioblastoma Multiforme

Treatments

Drug: ERAS-801

Study type

Interventional

Funder types

Industry

Identifiers

NCT05222802

ERAS-801-01

Details and patient eligibility

About

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.

Full description

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).

Enrollment

52 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Dose Escalation (Part 1)

Experimental group

Description:

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.

Treatment:

Drug: ERAS-801

Dose Expansion (Part 2)

Experimental group

Description:

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.

Treatment:

Drug: ERAS-801