Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities

Keywords

RET-altered Non Small Cell Lung Cancer RET-altered Solid Tumors Carcinoma, Non-Small-Cell Lung Congenital Abnormalities TAS0953/HM06

Eligibility

You can join if…

Open to people ages 18 years and up

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 or liquid biopsy
  • Documented progression of disease following existing therapies deemed by the Investigator to have demonstrated clinical benefit or unable to receive such therapies.
  • 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:

  • Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with primary 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

You CAN'T join if...

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.

Locations

  • Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868-3298 United States
  • Stanford Cancer Center accepting new patients
    Stanford California 94305-5826 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Helsinn Healthcare SA
ID
NCT04683250
Phase
Phase 1/2
Study Type
Interventional
Last Updated