A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

NCT03093116 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA127-1024TPX-0005-01
• Study Type: interventional
• Target: 500
• Locations: 19 countries
• Sites: 165

Brief Summary

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

Locally Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

ALK; ROS1; NTRK; Sarcoma; Lung Neoplasms; Carcinoma, NSCL; NSCLC; Non Small Cell Lung; Thyroid Disease; Colonic Neoplasms; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Disease; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Neoplasms; Endocrine System Disease; Colorectol Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Disease; Colonic Disease; Intestinal Disease; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Non Small Cell Lung Cancer; Solid Tumors; Rearrangements; TRIDENT-1; TKI; TKI naive; TKI pretreated; Anti-tumor activity; Repotrectinib; Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicities (DLTs) (Phase 1)

  Define the dose limiting toxicities (DLTs) (Phase 1)

  Within 28 days of the first repotrectinib dose

• Recommended Phase 2 Dose (RP2D) (Phase 1)

  To determine the RP2D (Phase 1)

  Within 28 days of the last patient dosed in escalation

• Overall Response Rate (ORR) Phase 2

  To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)

  Two to three years after first dose of repotrectinib dose

Secondary Outcomes (13)

• Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 1)

  Up to 72 hours post dose

• Area under the plasma concentration time curve (AUC) of repotrectinib (TPX-0005) (Phase 1)

  Up to 72 hours post dose

• Area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1)

  Up to 72 hours post dose

• Maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1)

  Up to 72 hours post dose

• Area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1)

  Up to 24 hours post dose

Study Arms (1)

Repotrectinib (TPX-0005)

EXPERIMENTAL

Phase 1 Oral repotrectinib (TPX-0005): Phase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study. Phase 2 Oral repotrectinib (TPX-0005): 6 distinct expansion cohorts * EXP-1: ROS1 TKI-naïve ROS1+ NSCLC * EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC * EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) * EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) * EXP-5: TRK TKI-naïve NTRK+ solid tumors * EXP-6: TRK TKI-pretreated NTRK+ solid tumors

Drug: Oral repotrectinib (TPX-0005)

Interventions

Oral repotrectinib (TPX-0005) DRUG

Oral repotrectinib (TPX-0005) capsules.

Also known as: repotrectinib

Repotrectinib (TPX-0005)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
• ECOG PS 0-1.
• Age ≥18 (or age ≥ 20 of age as required by local regulation).
• Capability to swallow capsules intact (without chewing, crushing, or opening).
• At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
• Prior cytotoxic chemotherapy is allowed.
• Prior immunotherapy is allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
• Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion.
• Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either:
• a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility.
• Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor.

You may not qualify if:

• i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors
• Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
• Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
• Life expectancy ≥ 3 months.
• Concurrent participation in another therapeutic clinical trial.
• Symptomatic brain metastases or leptomeningeal involvement.
• History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years.
• Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry
• Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) \> 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval.
• Known active infections (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
• Peripheral neuropathy of CTCAE ≥grade 2.
• History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.

Sponsors & Collaborators

• Turning Point Therapeutics, Inc.: lead
• Zai Lab (Shanghai) Co., Ltd.: collaborator

Study Sites (165)

Local Institution - 2129

Duarte, California, 91010, United States

COMPLETED

Local Institution - 2120

Glendale, California, 91206, United States

COMPLETED

Local Institution - 2136

La Jolla, California, 92037, United States

WITHDRAWN

Local Institution - 2114

La Jolla, California, 92093, United States

COMPLETED

Local Institution - 2121

Long Beach, California, 90813, United States

COMPLETED

Local Institution - 2101

Orange, California, 92868, United States

COMPLETED

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Local Institution - 2126

Santa Rosa, California, 95403, United States

COMPLETED

Local Institution - 1003

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Local Institution - 2103

Aurora, Colorado, 80045, United States

COMPLETED

Local Institution - 2106

Washington D.C., District of Columbia, 20007, United States

COMPLETED

Local Institution - 2110

Washington D.C., District of Columbia, 20016, United States

COMPLETED

Local Institution - 2128

Hollywood, Florida, 33021, United States

COMPLETED

Local Institution - 2113

Tampa, Florida, 33612, United States

COMPLETED

Local Institution - 2139

Athens, Georgia, 30607, United States

COMPLETED

Local Institution - 2134

Columbus, Georgia, 31904, United States

COMPLETED

Local Institution - 2125

Chicago, Illinois, 60637, United States

COMPLETED

Local Institution - 2142

Peoria, Illinois, 61615, United States

COMPLETED

Local Institution - 2116

New Orleans, Louisiana, 70121, United States

NOT YET RECRUITING

Local Institution - 2133

Baltimore, Maryland, 21210, United States

COMPLETED

Local Institution - 2104

Boston, Massachusetts, 02114, United States

COMPLETED

Local Institution - 1004

Boston, Massachusetts, 02214, United States

NOT YET RECRUITING

Local Institution - 2131

Boston, Massachusetts, 02215, United States

COMPLETED

Local Institution - 2105

Ann Arbor, Michigan, 48109, United States

COMPLETED

Local Institution - 2111

Detroit, Michigan, 48201, United States

COMPLETED

Local Institution - 2140

Detroit, Michigan, 48202-2608, United States

COMPLETED

Local Institution - 2132

Saint Paul, Minnesota, 55101, United States

COMPLETED

Local Institution - 2147

Bolivar, Missouri, 65613, United States

COMPLETED

Local Institution - 2115

St Louis, Missouri, 63110, United States

COMPLETED

Local Institution - 2122

New Brunswick, New Jersey, 08901, United States

COMPLETED

Local Institution - 2117

New York, New York, 10016, United States

COMPLETED

Local Institution - 2102

New York, New York, 10065, United States

COMPLETED

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Local Institution - 2144

Goldsboro, North Carolina, 27534, United States

COMPLETED

Local Institution - 2112

Canton, Ohio, 44718, United States

COMPLETED

Local Institution - 2143

Cincinnati, Ohio, 45220, United States

COMPLETED

Local Institution - 2109

Cleveland, Ohio, 44195, United States

COMPLETED

Local Institution - 2123

Columbus, Ohio, 43210, United States

COMPLETED

Local Institution - 2119

Toledo, Ohio, 43614, United States

COMPLETED

Local Institution - 2108

Philadelphia, Pennsylvania, 19111-2497, United States

COMPLETED

Local Institution - 2148

Memphis, Tennessee, 38120, United States

COMPLETED

Local Institution - 2130

Dallas, Texas, 75390, United States

COMPLETED

Local Institution - 2127

Houston, Texas, 77030, United States

COMPLETED

Local Institution - 2138

Houston, Texas, 77030, United States

COMPLETED

Local Institution - 2146

Kingwood, Texas, 77339, United States

COMPLETED

Local Institution - 2137

Fairfax, Virginia, 22031, United States

COMPLETED

Local Institution - 2107

Seattle, Washington, 98109, United States

COMPLETED

Local Institution - 2141

Tacoma, Washington, 98405, United States

WITHDRAWN

Local Institution - 2145

Appleton, Wisconsin, 54911, United States

COMPLETED

Local Institution - 6102

Camperdown, New South Wales, 2050, Australia

COMPLETED

Local Institution - 6103

Adelaide, South Australia, 5042, Australia

COMPLETED

Local Institution - 6101

Melbourne, Victoria, 3000, Australia

COMPLETED

Local Institution - 3301

East Melbourne, 3002, Australia

COMPLETED

Local Institution - 4802

Antwerp, 2650, Belgium

COMPLETED

Local Institution - 4801

Leuven, 3000, Belgium

COMPLETED

Local Institution - 2202

Edmonton, Alberta, T6G 1Z2, Canada

COMPLETED

Local Institution - 2205

Vancouver, British Columbia, V5Z 4E7, Canada

WITHDRAWN

Local Institution - 2201

Toronto, Ontario, M5G 2M9, Canada

COMPLETED

Local Institution - 6503

Toronto, Ontario, M5G 2M9, Canada

ACTIVE NOT RECRUITING

Local Institution - 2203

Ontario, L6R 37R, Canada

COMPLETED

Local Institution - 2204

Ottawa, K1H 8L6, Canada

COMPLETED

Local Institution - 6702

Beijing, Beijing Municipality, 100021, China

COMPLETED

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center

Daping, Chongqing Municipality, 00000, China

RECRUITING

Local Institution - 6719

Fuzhou, Fujian, 000000, China

COMPLETED

The First Affiliated hospital of Xiamen University-oncology

Xiamen, Fujian, 361003, China

RECRUITING

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Local Institution - 6733

Guangzhou, Guangdong, 510120, China

COMPLETED

Local Institution - 6505

Shenzhen, Guangdong, 518053, China

ACTIVE NOT RECRUITING

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

Local Institution - 6504

Shatin, HONG KONG, 999077, China

ACTIVE NOT RECRUITING

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department

Wuhan, Hubei, 430022, China

RECRUITING

Local Institution - 6705

Changsha, Hunan, 410011, China

COMPLETED

Hunan Cancer Hospital-thoracic oncology II

Changsha, Hunan, 410013, China

RECRUITING

Local Institution - 6748

Nanjing, Jiangsu, 210008, China

COMPLETED

XuZhou Central Hospital/Oncology Department

Xuzhou, Jiangsu, 00000, China

RECRUITING

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, 130012, China

RECRUITING

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, 130012, China

RECRUITING

The first hospital of Jilin university-Oncology Department

Changchun, Jilin, 130021, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110801, China

RECRUITING

Tangdu Hospital

Xi'an, Shan3xi, 710038, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

Sichuan Cancer Hospital/Medical Oncology Department

Chengdu, Sichuan, 00000, China

RECRUITING

The First Hospital Affiliated To AMU - Southwest Hospital

Chongqing, Sichuan, 400030, China

RECRUITING

Local Institution - 6725

Hangzhou, Zhejiang, 310016, China

COMPLETED

Zhejiang Cancer Hospital-Oncology

Hangzhou, Zhejiang, 310022, China

RECRUITING

The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine

Changsha, 00000, China

RECRUITING

West China Hospital Sichuan University/Lung cancer center

Chengdu, 00000, China

RECRUITING

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, 310003, China

RECRUITING

Anhui Provincial Hospital

Hefei, 230001, China

RECRUITING

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Weifang People's Hospital/Medical Oncology Department

Weifang, 00000, China

RECRUITING

Henan Cancer Hospital/The 1st pneumology department

Zhengzhou, 00000, China

RECRUITING

Local Institution - 4901

Copenhagen, 2100, Denmark

COMPLETED

Local Institution - 4201

Marseille, Bouches-du-Rhône, 13005, France

COMPLETED

Local Institution - 4207

Brest, 29200, France

COMPLETED

Local Institution - 4204

Dijon, 21079, France

COMPLETED

Local Institution - 4206

Grenoble, 38043, France

COMPLETED

Centre Antoine-Lacassagne

Nice, 06189, France

RECRUITING

Chu Poitiers

Poitiers, 86000, France

RECRUITING

Local Institution - 4203

Saint-Mandé, 94163, France

COMPLETED

Institute Gustave Roussy

Villejuif, 98405, France

RECRUITING

Local Institution - 4704

Berlin, 13125, Germany

COMPLETED

Local Institution - 4701

Cologne, 50937, Germany

COMPLETED

Local Institution - 4703

Dresden, 01307, Germany

COMPLETED

Local Institution - 4702

Heidelberg, 69120, Germany

COMPLETED

Local Institution - 6502

Hong Kong, 0, Hong Kong

ACTIVE NOT RECRUITING

Local Institution - 6501

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Local Institution - 5101

Budapest, 1083, Hungary

COMPLETED

Local Institution - 5103

Budapest, 1121, Hungary

COMPLETED

Local Institution - 4301

Milan, MI, 20133, Italy

COMPLETED

Local Institution - 4306

Milan, 20122, Italy

COMPLETED

Local Institution - 4307

Palermo, 90146, Italy

WITHDRAWN

Local Institution - 4303

Pordenone, 33081, Italy

COMPLETED

Local Institution - 4304

Ravenna, 48121, Italy

NOT YET RECRUITING

Local Institution - 4305

Reggio Emilia, 42123, Italy

COMPLETED

Local Institution - 4308

Roma, 144, Italy

COMPLETED

Local Institution - 4302

Terni, 05100, Italy

COMPLETED

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan

RECRUITING

Osaka City General Hospital

Osaka, Osaka, 5340021, Japan

RECRUITING

National Cancer Center Hospital.

Chuo-ku, Tokyo, 1040045, Japan

RECRUITING

Tottori University Hospital

Yonago, Tottori, 683-8504, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

Nagoya University Hospital

Nagoya, 466-8560, Japan

RECRUITING

Osaka International Cancer institute

Osaka, 5418567, Japan

RECRUITING

Local Institution - 4502

Amsterdam, 1066 CX, Netherlands

COMPLETED

Local Institution - 4501

Groningen, 9713 GZ, Netherlands

COMPLETED

Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Local Institution - 4604

Lublin, 20-609, Poland

COMPLETED

Local Institution - 4605

Poznan, 60-693, Poland

COMPLETED

Local Institution - 4603

Szczecin, 70-784, Poland

COMPLETED

Local Institution - 4602

Warsaw, 02-781, Poland

COMPLETED

Local Institution - 6401

Singapore, 119074, Singapore

COMPLETED

Local Institution - 6402

Singapore, 169610, Singapore

COMPLETED

Local Institution - 3003

Seoul, Gangnam-gu, 06351, South Korea

COMPLETED

Local Institution - 6308

Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-763, South Korea

COMPLETED

Yonsei University Health System

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Local Institution - 3002

Seoul, Seoul Teugbyeolsi, 03080, South Korea

WITHDRAWN

Local Institution - 6301

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

COMPLETED

Local Institution - 6303

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

COMPLETED

Local Institution - 6306

Cheongju-si, 28644, South Korea

COMPLETED

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Local Institution - 6302

Seoul, 03722, South Korea

COMPLETED

Local Institution - 6307

Seoul, 05030, South Korea

COMPLETED

Local Institution - 6305

Seoul, 05505, South Korea

COMPLETED

Local Institution - 6304

Seoul, 06591, South Korea

COMPLETED

Local Institution - 4102

Barcelona, 08028, Spain

COMPLETED

Local Institution - 4101

Barcelona, 8035, Spain

COMPLETED

Local Institution - 4106

Madrid, 28033, Spain

COMPLETED

Local Institution - 4104

Madrid, 28040, Spain

COMPLETED

Local Institution - 4103

Madrid, 28041, Spain

COMPLETED

Local Institution - 4105

Madrid, 28050, Spain

COMPLETED

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO

Valencia, 46009, Spain

RECRUITING

Local Institution - 6201

Taiepi, 100, Taiwan

ACTIVE NOT RECRUITING

Local Institution - 6203

Tainan, 704, Taiwan

ACTIVE NOT RECRUITING

Local Institution - 6202

Taipei, 10449, Taiwan

COMPLETED

Local Institution - 4401

London, SW3 6JJ, United Kingdom

COMPLETED

Local Institution - 4402

London, W12 OHS, United Kingdom

COMPLETED

Local Institution - 4404

London, W1G 6AD, United Kingdom

COMPLETED

Local Institution - 4403

Manchester, M20 4BX, United Kingdom

COMPLETED

Local Institution - 4405

Sutton, SM2 5PT, United Kingdom

COMPLETED

Related Publications (4)

• Besse B, Lin JJ, Bazhenova L, Goto K, de Langen AJ, Kim DW, Wolf J, Springfeld C, Popat S, Lim DWT, Nagasaka M, Hong JY, Baik CS, Hervieu A, Moreno V, Yang N, Kollengode K, Yang H, Xu Y, Calvet CY, Yuan Y, Hammell AB, Drilon A, Solomon BJ. Repotrectinib in NTRK fusion-positive advanced solid tumors: a phase 1/2 trial. Nat Med. 2026 Feb 4. doi: 10.1038/s41591-025-04079-7. Online ahead of print.

  PMID: 41639379 DERIVED

• Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. doi: 10.1056/NEJMoa2302299.

  PMID: 38197815 DERIVED

• Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naive and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.

  PMID: 32269053 DERIVED

• Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.

  PMID: 30093503 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Sarcoma; Lung Neoplasms; Carcinoma; Thyroid Diseases; Colonic Neoplasms; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

repotrectinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms, Glandular and Epithelial; Colorectal Neoplasms; Digestive System Diseases; Neoplasms, Nerve Tissue; Bronchial Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 28, 2017
• Study Start: March 7, 2017
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); TW (3); GB (5); NL (2); CN (33); DK (1); IT (8); BE (2); CA (6); US (49); HK (2); PL (5); JP (9); AU (4); FR (8); KR (12); ES (8); SG (2); HU (2)