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Status:

RECRUITING

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

Lead Sponsor:

Taiho Pharmaceutical Co., Ltd.

Conditions:

RET-altered Non Small Cell Lung Cancer

RET-altered Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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 Tolera...

Eligibility Criteria

Inclusion

  • 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 naïve 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 months prior to the first dose of the study.
  • Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.
  • Measurable disease as determined by RECIST 1.1
  • If patient has brain and/or leptomeningeal metastases,(s)he should have:
  • asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
  • asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
  • Phase II :
  • Available RET-gene abnormalities determined on tissue or liquid biopsy
  • Locally advanced or metastatic:
  • NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;
  • NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors
  • patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Measurable disease as determined by RECIST 1.1
  • If patient has brain and/or leptomeningeal metastases,(s)he should have:
  • asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
  • asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
  • Adequate hematopoietic, hepatic and renal function

Exclusion

  • Common exclusion criteria for Phase 1 and Phase 2
  • Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
  • Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
  • Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
  • QT interval corrected using Fridericia's formula (QTcF) \>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP
  • Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.
  • Phase I Dose-Expansion - and Phase II specific exclusion criteria:
  • Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.

Key Trial Info

Start Date :

December 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2031

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT04683250

Start Date

December 16 2020

End Date

March 1 2031

Last Update

March 5 2025

Active Locations (17)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (17 locations)

1

Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868-3298

2

Stanford Cancer Center

Stanford, California, United States, 94305-5826

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

4

Henry Ford Hospital

Detroit, Michigan, United States, 48202