Actively Recruiting
Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Led by Taiho Pharmaceutical Co., Ltd. · Updated on 2026-03-03
244
Participants Needed
21
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Taiho Pharmaceutical Co., Ltd.
Lead Sponsor
L
Linical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, how the body processes, and the effects of TAS0953/HM06, a selective RET inhibitor, in adults with advanced solid tumors that have specific RET gene abnormalities. The study is conducted in two phases: Phase 1 focuses on finding the highest dose patients can tolerate and the best dose for Phase 2, while Phase 2 evaluates how well this dose works. This research is sponsored by Taiho Pharmaceutical Co., Ltd. and spans both Phase 1 and Phase 2 clinical trial stages. In the first phase, participants receive TAS0953/HM06 orally, starting at 20 mg twice daily, with continuous daily dosing in 21-day cycles. Dose escalation and expansion continue until the appropriate Phase 2 dose is determined. In the second phase, participants take the recommended dose twice daily in similar 21-day cycles. Treatment is given continuously during both phases to assess safety and efficacy across different patient groups, including those with prior exposure to similar inhibitors and those without. Throughout the study, participants undergo regular assessments such as physical exams, blood tests, and imaging scans to monitor tumor response and drug levels. In Phase 1, dose tolerance and pharmacokinetics are evaluated at the end of the first cycle and over approximately 10 months. Phase 2 participants are monitored for tumor response every 6 weeks for 6 months, then every 9 weeks during treatment, with follow-up extending up to two years. Safety is closely tracked through adverse event reporting and heart monitoring, with additional evaluations after treatment ends.
CONDITIONS
Brief Title
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 for Phase 1; 0 to 2 for Phase 2
- Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy
- Adequate hematopoietic, hepatic and renal function
- For Phase 1 Dose-Escalation: advanced solid tumors with measurable or non-measurable disease
- For Phase 1 Dose-Expansion: patients with RET gene fusion NSCLC, treatment-naive or prior exposure to RET selective inhibitors, with measurable disease
- For Phase 1 Dose-Expansion and Phase 2: patients with asymptomatic brain or leptomeningeal metastases meeting specified stability criteria
- For Phase 2: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure or no prior exposure to RET selective inhibitors, or advanced solid tumors with RET abnormalities who failed all available therapies
You will not qualify if you...
- Investigational agents or anticancer therapy within 5 half-lives prior to first dose
- Major surgery within 4 weeks prior to first dose or planned major surgery during study
- Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to first dose, or persisting side effects
- Clinically significant, uncontrolled cardiovascular disease including recent myocardial infarction, unstable angina, severe heart failure, or severe uncontrolled hypertension
- QTcF interval greater than 470 msec or history of prolonged QT syndrome or Torsades de pointes
- Treatment with strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 3 weeks prior to first dose
- Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations for Phase 1 Dose-Expansion and Phase 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive the RET inhibitor TAS0953/HM06 by oral dosing twice a day in repeated 21-day cycles until disease progression or discontinuation.
Visits approximately every 6 weeks for 6 months, then every 9 weeks during treatment
Duration - Up to approximately 2 years after last dose
After treatment ends, participants are monitored for safety and disease status for up to approximately 2 years.
Visits 7 days after last dose, then every 3 months
Trial Site Locations
Total: 21 locations
1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868-3298
Terminated
2
Stanford Cancer Center
Stanford, California, United States, 94305-5826
Terminated
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Terminated
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Terminated
5
START Midwest - Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49546
Terminated
6
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Terminated
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Terminated
8
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States, 37203
Terminated
9
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Terminated
10
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Actively Recruiting
11
Tohoku University Hospital
Sendai, Miyagi, Japan
Actively Recruiting
12
Okayama University Hospital
Okayama, Okayama-ken, Japan
Actively Recruiting
13
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Actively Recruiting
14
Osaka International Cancer Institute
Osaka, Osaka, Japan
Actively Recruiting
15
Shizuoka Cancer Center
Shizuoka, Shizuoka, Japan
Actively Recruiting
16
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
17
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
18
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Actively Recruiting
19
Kanagawa Cancer Center
Kanagawa, Japan
Actively Recruiting
20
Kurashiki Central Hospital
Okayama, Japan
Actively Recruiting
21
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
K
Kazuo Koba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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