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NCT04683250RECRUITINGIRB Ready

Study of RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

(MARGARET)

Sponsored by Taiho Pharmaceutical Co., Ltd.

Quick Self-Assessment

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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

Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.

Who Can Participate

Inclusion Criteria

Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block is also acceptable.
Adequate hematopoietic, hepatic and renal function Phase I Dose-Escalation - Specific inclusion criteria:
Advanced solid tumors
Measurable and/or non-measurable disease as determined by RECIST 1.1
If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic. Phase I Dose-Expansion - Specific inclusion criteria:
Patient with RET gene fusion :
Cohort 1, 3: locally advanced or metastatic NSCLC patients naΓ―ve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6

❓ 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

244 participants

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Gender

ALL

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Sponsor

Taiho Pharmaceutical Co., Ltd.

Study Locations

Choose your preferred location or select flexible during enrollment

TERMINATED

Orange

California

Location available
View Orange location page
TERMINATED

Stanford

California

Location available
View Stanford location page
TERMINATED

Boston

Massachusetts

Location available
View Boston location page
TERMINATED

Detroit

Michigan

Location available
View Detroit location page
TERMINATED

Grand Rapids

Michigan

Location available
View Grand Rapids location page
TERMINATED

New York

New York

Location available
View New York location page
TERMINATED

New York

New York

Location available
View New York location page
TERMINATED

Nashville

Tennessee

Location available
View Nashville location page
TERMINATED

Houston

Texas

Location available
View Houston 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

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Lung Cancer Treatment in Orange?

Join others in California exploring innovative treatment options through clinical research

Lung Cancer Treatment Options in Orange, California

If you're searching for Lung Cancer treatment in Orange, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Orange, Stanford, Boston 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 Lung Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 244 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Lung Cancer?

Potential Benefits

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

What to Expect

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

Frequently Asked Questions About This Lung Cancer 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: NCT04683250. 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.