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NCT05765812RECRUITINGIRB Ready

A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

Sponsored by Debiopharm International SA

Quick Self-Assessment

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1 of 116 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.

Who Can Participate

Inclusion Criteria

for Phase 1 and Phase 2:
Signed written informed consent approved before undertaking any study-specific procedures.
Age โ‰ฅ18 years of age.
Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
Adequate bone marrow, hepatic, and renal function.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Willing to practice highly effective methods of contraception.
Life expectancy of at least 3 months in the best judgment of the Investigator.
Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).
Participants receiving corticosteroids must be on a stable or decreasing dose of โ‰ค4 mg daily dexamethasone (or โ‰ค25 mg prednisone) for the 7 days prior to the start of study treatment.
Participants with seizures must be

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

116 participants

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Gender

ALL

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Sponsor

Debiopharm International SA

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Dallas

Texas

Location available
View Dallas location page
RECRUITING

Houston

Texas

Location available
View Houston location page
RECRUITING

San Antonio

Texas

Location available
View San Antonio location page
RECRUITING

Salt Lake City

Utah

Location available
View Salt Lake City location page
RECRUITING

Seattle

Washington

Location available
View Seattle location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Glioblastoma Treatment in Chicago?

Join others in Illinois exploring innovative treatment options through clinical research

Glioblastoma Treatment Options in Chicago, Illinois

If you're searching for Glioblastoma treatment in Chicago, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chicago, New York, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Glioblastoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Illinois
Now Enrolling
Up to 116 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Glioblastoma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Glioblastoma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Glioblastoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05765812. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.