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A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer

Study Purpose

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have histologically confirmed solid cancer that is locally advanced and metastatic and available standard treatment options have been exhausted.
  • - Have adequate organ function.
  • - ECOG PS 0-1.
Dose Escalation:
  • - Have measurable or non- measurable disease per RECIST criteria v1.1 or RANO.
  • - Any solid tumor with EGFR and / or HER2 aberration.
Dose Expansion:
  • - Have measurable disease per RECIST criteria v1.1 for solid tumor (excluding primary brain tumor) or RANO (for glioblastoma) - Cohort A: Non-small cell lung cancer (NSCLC) - Cohort B: HER2 positive breast cancer.
  • - Cohort C: Recurrent or refractory glioblastoma.
  • - Cohort D: Other solid tumors with EGFR or HER2 aberrations.

Exclusion Criteria:

  • - Non-stable brain metastases.
  • - Have significant cardiovascular disorder.
  • - Have not recovered from prior cancer treatment.
- A serious illness or medical condition

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04982926
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Taiho Oncology, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries France, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer, Breast Cancer
Additional Details

TAS2940 is a small molecule inhibitor of ERBB family proteins HER2 and EGFR. It has not been evaluated in human subjects yet. The study will be conducted in 2 parts, dose escalation and dose expansion. The dose escalation part will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally. The dose expansion part will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Arms & Interventions

Arms

Experimental: TAS2940 Dose Escalation

Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.

Experimental: Dose Expansion Non-small Cell Lung Cancer

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Experimental: Dose Expansion Breast Cancer

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Experimental: Dose Expansion Gliblastoma

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Experimental: Dose Expansion Solid tumors

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Interventions

Drug: - TAS2940

Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.

Drug: - TAS2940

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tennessee Oncology, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology

Nashville, Tennessee, 37203

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

International Sites

CLCC Gustave Roussy, Villejuif, Cedex, France

Status

Recruiting

Address

CLCC Gustave Roussy

Villejuif, Cedex, 94805

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