Actively Recruiting
Study of 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
532 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
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.
CONDITIONS
Official 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 as defined by regional regulatory requirements
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
- Presence of RET gene abnormalities confirmed by tissue or liquid biopsy
- Adequate blood, liver, and kidney function
- Advanced solid tumors for Phase 1 dose-escalation, with measurable or non-measurable disease
- Asymptomatic brain or leptomeningeal metastases if present
- For Phase 1 dose-expansion NSCLC patients with RET gene fusion: Cohorts 1 and 3 must be naive to RET inhibitors and no prior systemic anti-cancer treatment (except completed neo-adjuvant or adjuvant chemotherapy at least 6 months before)
- For Phase 1 dose-expansion NSCLC patients with RET gene fusion: Cohorts 2 and 4 may have prior RET inhibitor exposure
- Measurable disease per RECIST 1.1
- For Phase 2: locally advanced or metastatic NSCLC patients with or without prior RET inhibitor exposure, or advanced solid tumors with RET abnormalities who have exhausted other treatments
You will not qualify if you...
- Use of investigational or anticancer therapy within 5 half-lives before starting study drug
- Major surgery (except vascular access placement) within 4 weeks before starting study drug or planned during study
- Whole brain radiotherapy within 14 days or other palliative radiotherapy within 7 days before starting study drug, or ongoing side effects from such therapy
- Uncontrolled or significant cardiovascular diseases including recent heart attack, unstable angina, severe heart failure, or severe uncontrolled hypertension
- QT interval corrected with Fridericia's formula >470 msec, history or risk factors for prolonged QT syndrome or Torsades de pointes
- Treatment with strong CYP3A4 inhibitors within 1 week or inducers within 3 weeks before study drug start
- Presence of known activating mutations in EGFR, KRAS, ALK, HER2, ROS1, BRAF, or METex14 (Phase 1 dose-expansion and Phase 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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