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Ph I/II Study of NMS-03305293+TMZ in Adult Patients With Recurrent Glioblastoma

NCT04910022 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-19

No results posted yet for this study

Summary

Multicenter, open-label, single-arm Phase 1/2 study on the safety and efficacy of the combination of NMS-03305293 and temozolomide (TMZ) in adult patients with diffuse gliomas (Phase 1) and isocitrate dehydrogenase (IDH) wild type glioblastoma (Phase 2) at first relapse.

Conditions

Interventions

DRUG

NMS-03305293

Route of administration: Oral

DRUG

Temozolomide

Route of administration: Oral Commercially available temozolomide

Sponsors & Collaborators

  • Nerviano Medical Sciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2027-05-30
Completion
2027-09-07
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Netherlands
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT04910022 on ClinicalTrials.gov