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NCT04683250 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, sponsored by Taiho Pharmaceutical Co..

Recruiting
Registry status
Phase 1
Development phase
244
Enrollment target
20
Study locations

NCT04683250 is a Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors that is actively recruiting participants, run by Taiho Pharmaceutical Co.. The registered enrollment target is 244 participants. The trial reports 20 study locations across 13 states.

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The verdict

NCT04683250, a Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, is actively recruiting participants, sponsored by Taiho Pharmaceutical Co..

RECRUITING
Registry status
Phase 1
Development phase
244 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

RET-altered Non Small Cell Lung Cancer RET-altered Solid Tumors

Interventions

  • DRUG TAS0953/HM06

Study Locations (20)

Other

  • National Hospital Organization Kyushu Cancer Center - Fukuoka
  • Kanagawa Cancer Center - Kanagawa
  • Kurashiki Central Hospital - Okayama

California

  • Chao Family Comprehensive Cancer Center - Orange
  • Stanford Cancer Center - Stanford

Michigan

  • Henry Ford Hospital - Detroit
  • START Midwest - Cancer & Hematology Centers of Western Michigan - Grand Rapids

New York

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health - New York
  • Memorial Sloan Kettering Cancer Center - New York

Osaka

  • Kansai Medical University Hospital - Hirakata-shi
  • Osaka International Cancer Institute - Osaka

Tokyo

  • National Cancer Center Hospital - Chuo-ku
  • The Cancer Institute Hospital of JFCR - Koto-ku

Massachusetts

  • Massachusetts General Hospital - Boston

Tennessee

  • The Sarah Cannon Research Institute/Tennessee Oncology - Nashville

Trial Details

FieldValue
Enrollment Target 244 participants
Start Date 2020-12-16
Est. Completion 2031-03
Phase Phase 1

Sponsor

Taiho Pharmaceutical Co.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04683250

The ClinicalTrials.gov registry entry for NCT04683250 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Pharmaceutical Co., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with RET-altered Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which TAS0953/HM06 is the first listed.

NCT04683250 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT04683250 about?

NCT04683250 is a clinical study titled "Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities". 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.

What is the current status of trial NCT04683250?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2020-12-16. Estimated completion is 2031-03.

What conditions does trial NCT04683250 study?

This clinical trial studies the following conditions: RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors.

What interventions are being tested in trial NCT04683250?

The interventions under investigation include: TAS0953/HM06 (DRUG).

Who is sponsoring clinical trial NCT04683250?

This trial is sponsored by Taiho Pharmaceutical Co., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04683250 being conducted?

This trial has 20 study locations across California, Massachusetts, Michigan, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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RET-altered Non Small Cell Lung Cancer

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RET-altered Solid Tumors

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.