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Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Not Recruiting
Trial ID: NCT04683250
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
Stanford Investigator(s)
Heather Wakelee
Professor of Medicine (Oncology)
Eligibility
Inclusion Criteria:
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
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.
Intervention(s):
drug: TAS0953/HM06
drug: TAS0953/HM06
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Danielle Pancirer
+1 650-723-0186