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New treatment option for RET-altered Non Small Cell Lung Cancer
Official title Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
ClinicalTrials.gov ID: NCT04683250
What this study is testing
What is TAS0953/HM06?
TAS0953/HM06 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ret-altered non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ages Eligible for Study: \- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region) Phase I - Common...
- 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...
- Adequate hematopoietic, hepatic and renal function Phase I Dose-Escalation - Specific
- Advanced solid tumors
You likely 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...
- Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side...
- Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable...
- QT interval corrected using Fridericia's formula (QTcF) \>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de...
See the full eligibility criteria
- Ages Eligible for Study: \- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region) Phase I - Common 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 or cell pellet is also acceptable.
- Adequate hematopoietic, hepatic and renal function Phase I Dose-Escalation - Specific
- 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
- 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...
- 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
- 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...
- 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...
- Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Stanford, California, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Kashiwa-shi, Chiba, Japan
- Sendai, Miyagi, Japan
- Okayama, Okayama-ken, Japan
- Hirakata-shi, Osaka, Japan
- Osaka, Osaka, Japan
- Shizuoka, Shizuoka, Japan
- Chuo-ku, Tokyo, Japan
- Koto-ku, Tokyo, Japan
- Fukuoka, Japan
- Kanagawa, Japan
- Okayama, Japan
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Stanford, California, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.