Study of RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities
NCT ID: NCT04683250
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
244 participants
INTERVENTIONAL
2020-12-16
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TAS0953/HM06 Phase 1
Dose escalation and dose expansion until recommended Phase 2 dose determined
TAS0953/HM06
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
TAS0953/HM06 Phase 2
Treatment phase at recommended Phase 2 dose in three different populations
TAS0953/HM06
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
Interventions
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TAS0953/HM06
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
TAS0953/HM06
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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
* 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.
* Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
18 Years
ALL
No
Sponsors
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Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Center
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
START Midwest - Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Shizuoka Cancer Center
Shunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HM06-19-26
Identifier Type: -
Identifier Source: org_study_id
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