Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
a study on Lung Cancer Non-Small Cell Lung Cancer Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedestimated 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, Non-Small-Cell Lung Carcinoma, 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 research study
- Study Type
- Interventional
- Participants
- Expecting 202 study participants
- Last Updated
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