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5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours

NCT06630260 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-01-21

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday / Thursday or Tuesday / Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg.

Once a treatment in any biomarker arm has met the "GO" decision (≥3 successes/12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.

Conditions

  • Glioblastoma Multiforme (GBM)
  • Glioblastoma Multiform (Grade IV Astrocytoma)
  • Diffuse Hemispheric Glioma, H3 G34-Mutant
  • Malignant Primary Gliomas

Interventions

DRUG

Avutometinib

Supplied as 0.8mg capsules.

DRUG

Defactinib

Supplied as 200mg tablets.

DRUG

Temozolomide

Temozolomide will be supplied as 5, 20, 100, 140, 180 or 250 mg hard capsules.

Sponsors & Collaborators

  • Minderoo Foundation

    collaborator UNKNOWN

  • Verastem, Inc.

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Juanita Lopez, MD, PhD · National Health Service, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2029-09-30
Completion
2030-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT06630260 on ClinicalTrials.gov