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

Trial ID or NCT#

NCT04683250

Status

recruiting iconRECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:
    1. * 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
  2. Phase I Dose-Escalation - Specific inclusion criteria:
    1. * 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.
  3. Phase I Dose-Expansion - Specific inclusion criteria:
    1. * 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:
    2. * 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.
  4. Phase II :
    1. * Available RET-gene abnormalities determined on tissue or liquid biopsy* Locally advanced or metastatic:
    2. * 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:
    3. * 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:
  1. Common exclusion criteria for Phase 1 and Phase 2
    1. * 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.
  2. Phase I Dose-Expansion - and Phase II specific exclusion criteria:
    1. * Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
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Investigator(s)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor

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Contact

Danielle Pancirer
+1 650-723-0186

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View on ClinicalTrials.gov