Actively Recruiting
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Led by Turning Point Therapeutics, Inc. · Updated on 2026-04-03
500
Participants Needed
165
Research Sites
573 weeks
Total Duration
On this page
Sponsors
T
Turning Point Therapeutics, Inc.
Lead Sponsor
Z
Zai Lab (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
CONDITIONS
Official Title
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor with ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement (Phase 1) or ROS1 or NTRK1-3 gene fusion (Phase 2).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Age 12 years or older (or 20 years as per local regulation).
- Ability to swallow capsules intact.
- At least one measurable target lesion per RECIST v1.1 (including CNS-only measurable disease).
- Prior cytotoxic chemotherapy and immunotherapy allowed (Phase 1).
- Resolution of acute toxic effects from prior therapies to Grade 1 or less (excluding alopecia).
- Patients with asymptomatic CNS metastases or leptomeningeal carcinomatosis meeting protocol criteria.
- Baseline laboratory values within specified limits for blood counts, liver and kidney function, and electrolytes.
- Life expectancy of at least 3 months.
- For Phase 2, documented ROS1 or NTRK1-3 gene fusion confirmed by local and central laboratory testing.
- Willingness and ability to provide informed consent or assent (for ages 12-17).
- Assignment into one of six expansion cohorts based on prior therapy and tumor gene status (Phase 2).
You will not qualify if you...
- Concurrent participation in another therapeutic clinical trial.
- Symptomatic brain metastases or leptomeningeal involvement.
- History of previous cancer requiring therapy within past 2 years, except certain skin or in situ carcinomas.
- Major surgery within 4 weeks or recent radiation therapy within 2 weeks before treatment.
- Clinically significant cardiovascular disease or ongoing serious heart rhythm problems.
- Prolonged QTc interval or other ECG abnormalities increasing risk of arrhythmia.
- Known active infections including HIV.
- Gastrointestinal diseases affecting drug absorption.
- Peripheral neuropathy of Grade 2 or higher.
- History of severe interstitial lung disease or pneumonitis except prior radiation pneumonitis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 165 locations
1
Local Institution - 2129
Duarte, California, United States, 91010
Completed
2
Local Institution - 2120
Glendale, California, United States, 91206
Completed
3
Local Institution - 2136
La Jolla, California, United States, 92037
Withdrawn
4
Local Institution - 2114
La Jolla, California, United States, 92093
Completed
5
Local Institution - 2121
Long Beach, California, United States, 90813
Completed
6
Local Institution - 1001
Orange, California, United States, 92868
Completed
7
Local Institution - 2101
Orange, California, United States, 92868
Completed
8
St Joseph Heritage Healthcare
Santa Rosa, California, United States, 95403
Actively Recruiting
9
Local Institution - 1003
Aurora, Colorado, United States, 80045
Completed
10
Local Institution - 2103
Aurora, Colorado, United States, 80045
Completed
11
Local Institution - 2106
Washington D.C., District of Columbia, United States, 20007
Completed
12
Local Institution - 2110
Washington D.C., District of Columbia, United States, 20016
Completed
13
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
14
Local Institution - 2113
Tampa, Florida, United States, 33612
Completed
15
University Cancer and Blood Center
Athens, Georgia, United States, 30607
Actively Recruiting
16
Local Institution - 2134
Columbus, Georgia, United States, 31904
Completed
17
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
18
Local Institution - 2142
Peoria, Illinois, United States, 61615
Completed
19
Local Institution - 2116
New Orleans, Louisiana, United States, 70121
Not Yet Recruiting
20
Local Institution - 2133
Baltimore, Maryland, United States, 21210
Completed
21
Massachusetts General Hospital,
Boston, Massachusetts, United States, 02114
Actively Recruiting
22
Local Institution - 1004
Boston, Massachusetts, United States, 02214
Completed
23
Local Institution - 2131
Boston, Massachusetts, United States, 02215
Completed
24
Local Institution - 2105
Ann Arbor, Michigan, United States, 48109
Completed
25
Local Institution - 2111
Detroit, Michigan, United States, 48201
Completed
26
Local Institution - 2140
Detroit, Michigan, United States, 48202-2608
Completed
27
Local Institution - 2132
Saint Paul, Minnesota, United States, 55101
Completed
28
Local Institution - 2147
Bolivar, Missouri, United States, 65613
Completed
29
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States, 63110
Actively Recruiting
30
Local Institution - 2122
New Brunswick, New Jersey, United States, 08901
Completed
31
Local Institution - 2117
New York, New York, United States, 10016
Completed
32
Local Institution - 1002
New York, New York, United States, 10065
Active, Not Recruiting
33
Local Institution - 2102
New York, New York, United States, 10065
Completed
34
Local Institution - 2144
Goldsboro, North Carolina, United States, 27534
Completed
35
Local Institution - 2112
Canton, Ohio, United States, 44718
Completed
36
Local Institution - 2143
Cincinnati, Ohio, United States, 45220
Completed
37
Local Institution - 2109
Cleveland, Ohio, United States, 44195
Completed
38
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
39
Local Institution - 2119
Toledo, Ohio, United States, 43614
Completed
40
Local Institution - 2108
Philadelphia, Pennsylvania, United States, 19111-2497
Completed
41
Baptist Memorial Hospital Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
42
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
43
Local Institution - 2127
Houston, Texas, United States, 77030
Completed
44
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
45
Local Institution - 2146
Kingwood, Texas, United States, 77339
Completed
46
Local Institution - 2137
Fairfax, Virginia, United States, 22031
Completed
47
Local Institution - 2107
Seattle, Washington, United States, 98109
Completed
48
Local Institution - 2141
Tacoma, Washington, United States, 98405
Withdrawn
49
Local Institution - 2145
Appleton, Wisconsin, United States, 54911
Completed
50
Chris O'Brien LifeHouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
51
Local Institution - 6103
Adelaide, South Australia, Australia, 5042
Completed
52
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
53
Local Institution - 3301
East Melbourne, Australia, 3002
Completed
54
Local Institution - 4802
Antwerp, Belgium, 2650
Completed
55
Local Institution - 4801
Leuven, Belgium, 3000
Completed
56
Local Institution - 2202
Edmonton, Alberta, Canada, T6G 1Z2
Completed
57
Local Institution - 2205
Vancouver, British Columbia, Canada, V5Z 4E7
Withdrawn
58
Local Institution - 2201
Toronto, Ontario, Canada, M5G 2M9
Completed
59
Local Institution - 6503
Toronto, Ontario, Canada, M5G 2M9
Active, Not Recruiting
60
Local Institution - 2203
Ontario, Canada, L6R 37R
Completed
61
Local Institution - 2204
Ottawa, Canada, K1H 8L6
Completed
62
Local Institution - 6702
Beijing, Beijing Municipality, China, 100021
Completed
63
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
64
Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center
Daping, Chongqing Municipality, China, 00000
Actively Recruiting
65
Local Institution - 6719
Fuzhou, Fujian, China, 000000
Completed
66
The First Affiliated hospital of Xiamen University-oncology
Xiamen, Fujian, China, 361003
Actively Recruiting
67
Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
68
Local Institution - 6733
Guangzhou, Guangdong, China, 510120
Completed
69
Local Institution - 6505
Shenzhen, Guangdong, China, 518053
Active, Not Recruiting
70
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
Actively Recruiting
71
Local Institution - 6504
Shatin, HONG KONG, China, 999077
Active, Not Recruiting
72
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department
Wuhan, Hubei, China, 430022
Actively Recruiting
73
Local Institution - 6705
Changsha, Hunan, China, 410011
Completed
74
Hunan Cancer Hospital-thoracic oncology II
Changsha, Hunan, China, 410013
Actively Recruiting
75
Local Institution - 6748
Nanjing, Jiangsu, China, 210008
Completed
76
XuZhou Central Hospital/Oncology Department
Xuzhou, Jiangsu, China, 00000
Actively Recruiting
77
Jilin Cancer Hospital/Medical Oncology Department
Changchun, Jilin, China, 130012
Actively Recruiting
78
Jilin Cancer Hospital/Medical Oncology Department
Changchun, Jilin, China, 130012
Actively Recruiting
79
The first hospital of Jilin university-Oncology Department
Changchun, Jilin, China, 130021
Actively Recruiting
80
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
81
Tangdu Hospital
Xi'an, Shan3xi, China, 710038
Actively Recruiting
82
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
83
Sichuan Cancer Hospital/Medical Oncology Department
Chengdu, Sichuan, China, 00000
Actively Recruiting
84
The First Hospital Affiliated To AMU - Southwest Hospital
Chongqing, Sichuan, China, 400030
Actively Recruiting
85
Local Institution - 6725
Hangzhou, Zhejiang, China, 310016
Completed
86
Zhejiang Cancer Hospital-Oncology
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
87
The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine
Changsha, China, 00000
Actively Recruiting
88
West China Hospital Sichuan University/Lung cancer center
Chengdu, China, 00000
Actively Recruiting
89
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, China, 310003
Actively Recruiting
90
Anhui Provincial Hospital
Hefei, China, 230001
Actively Recruiting
91
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
92
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
93
Weifang People's Hospital/Medical Oncology Department
Weifang, China, 00000
Actively Recruiting
94
Henan Cancer Hospital/The 1st pneumology department
Zhengzhou, China, 00000
Actively Recruiting
95
Local Institution - 4901
Copenhagen, Denmark, 2100
Completed
96
Local Institution - 4201
Marseille, Bouches-du-Rhône, France, 13005
Completed
97
Local Institution - 4207
Brest, France, 29200
Completed
98
Centre Georges-Francois Leclerc
Dijon, France, 21079
Actively Recruiting
99
Centre Hospitalier Universitarie Grenoble Alpes (Chuga)
Grenoble, France, 38043
Actively Recruiting
100
Centre Antoine-Lacassagne
Nice, France, 06189
Actively Recruiting
101
Local Institution - 4208
Poitiers, France, 86000
Completed
102
Local Institution - 4203
Saint-Mandé, France, 94163
Completed
103
Institute Gustave Roussy
Villejuif, France, 98405
Actively Recruiting
104
Local Institution - 4704
Berlin, Germany, 13125
Completed
105
Local Institution - 4701
Cologne, Germany, 50937
Completed
106
Local Institution - 4703
Dresden, Germany, 01307
Completed
107
Local Institution - 4702
Heidelberg, Germany, 69120
Completed
108
Local Institution - 6502
Hong Kong, Hong Kong, 0
Active, Not Recruiting
109
Local Institution - 6501
Hong Kong, Hong Kong
Active, Not Recruiting
110
Local Institution - 5101
Budapest, Hungary, 1083
Completed
111
Local Institution - 5103
Budapest, Hungary, 1121
Completed
112
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy, 20133
Actively Recruiting
113
Local Institution - 4306
Milan, Italy, 20122
Completed
114
Local Institution - 4307
Palermo, Italy, 90146
Withdrawn
115
Centro di Riferimento Oncologico
Pordenone, Italy, 33081
Actively Recruiting
116
Local Institution - 4304
Ravenna, Italy, 48121
Not Yet Recruiting
117
Local Institution - 4305
Reggio Emilia, Italy, 42123
Completed
118
IRCCS Istituto Regina Elena Oncologia Medica 2
Roma, Italy, 144
Actively Recruiting
119
Local Institution - 4302
Terni, Italy, 05100
Completed
120
Ehime University Hospital
Tōon, Ehime, Japan, 791-0295
Actively Recruiting
121
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
122
Kanagawa cancer center
Yokohama, Kanagawa, Japan, 2418515
Actively Recruiting
123
Osaka City General Hospital
Osaka, Osaka, Japan, 5340021
Actively Recruiting
124
National Cancer Center Hospital.
Chuo-ku, Tokyo, Japan, 1040045
Actively Recruiting
125
Tottori University Hospital
Yonago, Tottori, Japan, 683-8504
Actively Recruiting
126
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
127
Nagoya University Hospital
Nagoya, Japan, 466-8560
Actively Recruiting
128
Osaka International Cancer institute
Osaka, Japan, 5418567
Actively Recruiting
129
Local Institution - 4502
Amsterdam, Netherlands, 1066 CX
Completed
130
Local Institution - 4501
Groningen, Netherlands, 9713 GZ
Completed
131
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
132
Local Institution - 4604
Lublin, Poland, 20-609
Completed
133
Local Institution - 4605
Poznan, Poland, 60-693
Completed
134
Local Institution - 4603
Szczecin, Poland, 70-784
Completed
135
Local Institution - 4602
Warsaw, Poland, 02-781
Completed
136
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
137
National Cancer Center Singapore
Singapore, Singapore, 169610
Actively Recruiting
138
Local Institution - 3003
Seoul, Gangnam-gu, South Korea, 06351
Completed
139
Chonnam National University Hwasun Hospital
Hwasun-eup, Hwasun-gun, Jeollanam-do, South Korea, 519-763
Actively Recruiting
140
Local Institution - 3002
Seoul, Seodaemun-gu, South Korea, 03722
Completed
141
Local Institution - 3002
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Withdrawn
142
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Actively Recruiting
143
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Actively Recruiting
144
Local Institution - 6306
Cheongju-si, South Korea, 28644
Completed
145
Local Institution - 3001
Seoul, South Korea, 03080
Completed
146
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
147
Local Institution - 6307
Seoul, South Korea, 05030
Completed
148
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
149
Local Institution - 6304
Seoul, South Korea, 06591
Completed
150
Local Institution - 4102
Barcelona, Spain, 08028
Completed
151
Hospital Unversitario Val D'Hebrón
Barcelona, Spain, 8035
Actively Recruiting
152
Local Institution - 4106
Madrid, Spain, 28033
Completed
153
START Madrid-FJD
Madrid, Spain, 28040
Actively Recruiting
154
Local Institution - 4103
Madrid, Spain, 28041
Completed
155
Hospital Universitario HM Sanchinarro CIOCC
Madrid, Spain, 28050
Actively Recruiting
156
Local Institution - 4108
Pamplona, Spain, 31008
Completed
157
Local Institution - 4107
Valencia, Spain, 46009
Completed
158
Local Institution - 6201
Taiepi, Taiwan, 100
Active, Not Recruiting
159
Local Institution - 6203
Tainan, Taiwan, 704
Active, Not Recruiting
160
Local Institution - 6202
Taipei, Taiwan, 10449
Completed
161
Local Institution - 4401
London, United Kingdom, SW3 6JJ
Completed
162
Local Institution - 4402
London, United Kingdom, W12 OHS
Completed
163
Local Institution - 4404
London, United Kingdom, W1G 6AD
Completed
164
Local Institution - 4403
Manchester, United Kingdom, M20 4BX
Completed
165
Local Institution - 4405
Sutton, United Kingdom, SM2 5PT
Completed
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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