Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC

RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: Tislelizumab; Drug: Sorafenib

• Study Type: Interventional
• Enrollment (Actual): 674
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230601
      • Anhui Medical University - The Second Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer hospital
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China
      • 302 Military Hospital of China
    • Beijing, Beijing, China
      • Beijing Youan Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Cancer Hopital Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital , Sun Yat-sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 400037
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430023
      • Wuhan Union Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Bayi Hospital
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China
      • The first hospital of Jilin University
    • Changchun, Jilin, China
      • Jilin Cancer Hospital
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University
    • Weifang, Shandong, China, 261000
      • WeiFang People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200032
      • Shanghai Cancer Hospital of Fudan University
  • Shanxi
    • Xian, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Sichuan, Sichuan, China, 610072
      • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
  • Wuhan
    • Wuhan, Wuhan, China, 430071
      • Zhongnan Hospital of Wuhan University
  • Zhejiang
    • HangZhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Brno-Mesto
    • Brno, Brno-Mesto, Czechia, 625 00
      • Fakultni nemocnice Brno
• France
  • Amiens
    • Somme, Amiens, France, 80054
      • CHU Amiens-Hopital Nord - Hépato-Gastroentérologie
  • Basse-Normandie
    • Caen, Cedex 05, Basse-Normandie, France, 14033
      • CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N
  • Bretagne
    • Plérin, Bretagne, France, 22190
      • Hôpital Privé des Côtes d'Armor - Service oncologie
  • Champagne-Ardenne
    • Reims, Champagne-Ardenne, France, 51100
      • Hopital Robert DEBRE, CHU Reims
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25030
      • Hospitalier Jean Minjoz
  • Isere
    • La Tronche, Isere, France, 38700
      • CHU de Grenoble Alpes
  • Lie-de-France
    • Clichy Cedex, Lie-de-France, France, 92118
      • Bichat-Beaujon Service Inter Hospitalier De Cancerologie
    • Villejuif, Lie-de-France, France, 94800
      • Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 4400
      • CHU Nantes -hopital hotel Dieu
  • Lyon
    • Rahon, Lyon, France, 42270
      • CHU Saint Etienne
  • Nord
    • Lille, Nord, France, 59037
      • CHRU de Lille - Hopital Claude Huriez
  • Provence-Alpes-Côte-d'Azur
    • Nice, Provence-Alpes-Côte-d'Azur, France, 3200
      • CHU de Nice - Hôpital de l'Archet II
  • Rennes Cedex
    • Bretagne, Rennes Cedex, France
      • CHU Saint Eloi - Pôle Digestif
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94805
      • Gustave Roussy - Medical Oncology
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Hospital of Poitiers
• Germany
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Köln, Germany, 50937
    • Universitatsklinikum Koln
  • Leipzig, Germany, 4103
    • Universitätsklinikum Leipzig AöR
  • Mainz, Germany
    • Universitätsmedizin Mainz
  • Hessen
    • Frankfurt/Main, Hessen, Germany
      • Krankenhaus Nordwest gGmbH
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Maria Gonzalez-Carmona
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Stefan Pluntke
• Italy
  • Bologna, Italy, 40138
    • Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie
  • Cremona, Italy
    • PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology
  • Lecce, Italy, 73100
    • Ospedale Vito Fazzi, ASL Lecce
  • Modena, Italy
    • AOU Policlinico di Modena
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
  • Pavia, Italy, 27100
    • Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia
  • Roma, Italy, 144
    • Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
  • Torino, Italy
    • PO Umberto I, AO Ordine Mauriziano
  • Bari
    • Castellana Grotte, Bari, Italy, 70013
      • IRCCS Saverio De Bellis, AO Gastroenterologia
  • Belluno
    • Feltre, Belluno, Italy
      • Medical Oncology
  • Catani
    • Catania, Catani, Italy, 95123
      • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania
  • Veneto
    • Vicenza, Veneto, Italy
      • Ospedale S.Bortolo, AULSS n.6 Vicenza
• Japan
  • Fukuoka, Japan, 810-8563
    • Kyushu Medical Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Morioka, Japan
    • Iwate Medical University Hospital
  • Nishinomiya-shi, Japan, 663-8501
    • Hyogo College of Medicine Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Tottori, Japan, 683-8504
    • Tottori University Hospital
  • Wakayama-shi, Japan, 641-8509
    • Wakayama Medical University
  • Aiti [Aichi]
    • Toyoake, Aiti [Aichi], Japan, 470-1192
      • Fujita Health University Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0024
      • Ehime Prefectural Central Hospital - Gastroenterology
  • Gihu [Gifu]
    • Ogaki, Gihu [Gifu], Japan
      • Ogaki Municipal Hospital
  • Hokkaidô [Hokkaido]
    • Sapporo, Hokkaidô [Hokkaido], Japan, 060-8648
      • Hokkaido University Hospital - Gastroenterology
  • Isikawa [Ishikawa]
    • Kanazawa-shi, Isikawa [Ishikawa], Japan, 9208641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Kyôto [Kyoto]
    • Kyoto-shi, Kyôto [Kyoto], Japan, 602-8566
      • University Hospital, Kyoto Prefectural Univ of Medicine
  • Nagasaki
    • Omura, Nagasaki, Japan, 856-8562
      • Nagasaki Medical Center
  • Osaka
    • Osaka-sayama, Osaka, Japan, 589-8511
      • Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Tiba [Chiba]
    • Chiba, Tiba [Chiba], Japan, 260-8677
      • Chiba University Hospital
  • Tokyo
    • Chiyoda-Ku, Tokyo, Japan, 101-0062
      • Sasaki Foundation Kyoundo Hospital
  • Tôkyô [Tokyo]
    • Itabashi-ku, Tôkyô [Tokyo], Japan, 173-8610
      • Nihon University Itabashi Hospital - Gastroenterological surgery
    • Shibuya-ku, Tôkyô [Tokyo], Japan, 150-8935
      • JRC Medical Center
    • Shinjuku-ku, Tôkyô [Tokyo], Japan, 162-8655
      • National Center for Global Health and Medicine
  • Ôsaka [Osaka]
    • Osaka, Ôsaka [Osaka], Japan, 534-0021
      • Osaka City General Hospital
    • Osaka, Ôsaka [Osaka], Japan, 540-0006
      • Osaka National Hospital
    • Osaka, Ôsaka [Osaka], Japan, 545-8586
      • Osaka City University Hospital
• Poland
  • Gdańsk, Poland, 80-211
    • Uniwersyteckie Centrum Kliniczne
  • Wroclaw, Poland, 51-149
    • Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-569
      • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
• Spain
  • Barcelona, Spain, 8035
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28050
    • Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC)
  • Valencia, Spain
    • Hospital Universitari i Politecnic La Fe
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain
      • Institut Catalá d´Oncología (I.C.O.)
• Taiwan
  • Kaohsiung, Taiwan
    • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • New Taipei, Taiwan
    • Tri-Service General Hospital - Neihu Branch
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taichung, Taiwan
    • China Medical University Hospital - Transplantology - Taichung
  • Tainan, Taiwan, 705
    • National Cheng Kung University Hospital
  • Tainan, Taiwan
    • Chi Mei Medical Center - YongKang
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
• United Kingdom
  • Birmingham, United Kingdom, B152TH
    • Queen Elizabeth Hospital - Clinical Reasearch
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital London NHS Trust
  • Withington, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust - Oak Road Treatment Centre
• United States
  • California
    • Coronado, California, United States, 92118
      • Southern California Research Center
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare
    • Los Angeles, California, United States, 90095
      • University of California - Hematology and Oncology
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Tinley Park, Illinois, United States, 60487
      • Healthcare Research Network III, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2429
      • Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit
    • New Orleans, Louisiana, United States, 70121
      • University Medical Center New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Umdnj-Njms
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health/Monter Cancer Center
    • White Plains, New York, United States, 10601
      • White Plains Hospital Center for Cancer Care - Oncology
  • Ohio
    • Kettering, Ohio, United States, 45409
      • Precision Cancer Research / Dayton Physicians Network
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Hahnemann University Hospital - Gastroenterology Hepatology
    • Philadelphia, Pennsylvania, United States, 19124
      • Cancer Treatment Centers of America - Oncology
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center (VUMC)
  • Texas
    • San Antonio, Texas, United States, 78229
      • The Mays Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of HCC
2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
3. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only])
4. Measurable disease
5. Child-Pugh score A
6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
7. Adequate organ function

Key Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
2. Tumor thrombus involving main trunk of portal vein or inferior vena cava
3. Loco-regional therapy to the liver within 28 days before randomization
4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
7. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Tislelizumab & Safety Run-In Substudy [Japan Only]	Drug: Tislelizumab; 200 mg once every 3 weeks (Q3W), intravenous dosing (IV); Other Names: BGB-A317
Active Comparator: Arm B: Sorafenib	Drug: Sorafenib; 400 mg twice daily (BID), oral dosing; Other Names: Nexavar; BAY43-9006

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	From date of randomization up to 4 years, approximately
Safety Run-In Substudy[Japan only]: Percentage of participants with adverse events	From date of enrollment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Percentage of participants with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of tislelizumab in Japanese participants]	From the date of enrollment up to 28 days [DLT period].
Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of Tislelizumab	From first dose of study treatment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of tislelizumab	From first dose of study treatment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of tislelizumab	From first dose of study treatment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against tislelizumab at Cmin	From first dose of study treatment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings	From date of enrollment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings	From date of enrollment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings	From date of enrollment up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings	From date of enrollment up to 4 years, approximately.

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	From date of randomization up to 4 years, approximately
Progression-free survival (PFS)	From date of randomization up to 4 years, approximately
Duration of Response (DOR)	From first determination of an objective response up to 4 years, approximately
Time to Progression (TTP)	From date of randomization up to 4 years, approximately.
Health-Related Quality of Life (HRQoL)	From date of enrollment up to 4 years, approximately.
Disease Control Rate (DCR)	From first dose of study treatment up to 4 years, approximately
Clinical Benefit Rate (CBR)	From first dose of study treatment up to 4 years, approximately
Percentage of participants with adverse events	From date of screening up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)	From date of randomization up to 4 years, approximately.
Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)	From date of randomization up 4 years, approximately
Safety Run-In Substudy[Japan only]: Duration of Response (DOR)	From date of randomization up 4 years, approximately
Safety Run-In Substudy[Japan only]: Overall Survival (OS)	From date of randomization up 4 years, approximately
Safety Run-In Substudy[Japan only]: Anti-tislelizumab antibody	From first dose of study treatment up 4 years, approximately
Percentage of Participants With Clinically Significant Changes in Vital Signs Findings	From date of enrollment up to 4 years, approximately
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings	From date of enrollment up to 4 years, approximately
Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings	From date of enrollment up to 4 years, approximately
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings	From date of enrollment up to 4 years, approximately

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Yaxi Chen, MD, BeiGene

Publications and helpful links

General Publications

• Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Advanced liver cancer; RATIONALE-301
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Sorafenib; Tislelizumab
• Other Study ID Numbers: BGB-A317-301; 2017-002423-19 (EudraCT Number); CTR20170882 (Registry Identifier: Center for drug evaluation, CFDA); JapicCTI-194569 (Registry Identifier: Japic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No