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

Study Identifier:
HM06-19-26
CT.gov Identifier:
NCT04683250
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities.

To study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities.

Phase I aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase II Dose (RP2D) to be used in phase II.

To present the preliminary phase 1 safety and antitumor-activity results.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Pancreas
  • Solid Tumor
  • Thyroid
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: TAS0953/HM06 Phase 1 Dose escalation and dose expansion until recommended Phase 2 dose determined Drug: TAS0953/HM06 Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days Experimental: TAS0953/HM06 Phase 2 Treatment phase at recommended Phase 2 dose in three different populations Drug: TAS0953/HM06 Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Ages Eligible for Study:
    • - Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)
    • 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 criteria
    • 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.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Pancreas
    Solid Tumor
    Thyroid