Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide.

Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) [Part 2i] or mutated EGFR-expression (mutEGFR NSCLC) [Part 2ii], squamous NSCLC [Part 2iii], GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion [Part 4], participants MET amplification will receive IV ABBV-400 monotherapy in expansion [Part 5], participants MET mutation will receive IV ABBV-400 monotherapy in expansion [Part 6], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab [Part 7a], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets [Part 7b].

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Non-Small Cell Lung Cancer; Advanced Solid Tumors; Gastroesophageal Adenocarcinoma
• Intervention / Treatment: Drug: ABBV-400; Drug: Bevacizumab; Drug: Trifluridine/Tipiracil

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited /ID# 249995
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health /ID# 247667
• France
  • Dijon, France, 21079
    • Centre Georges François Leclerc /ID# 244450
  • Paris, France, 75015
    • AP-HP - Hopital Européen Georges Pompidou /ID# 250481
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Institut Bergonie /ID# 248028
  • Loire-Atlantique
    • Saint-Herblain, Loire-Atlantique, France, 44800
      • CHU Nantes - Hopital Laennec /ID# 244723
    • Saint-Herblain, Loire-Atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399
  • Provence-Alpes-Côte d'Azur Region
    • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
      • Centre Antoine-Lacassagne /ID# 231730
  • Rhone
    • Lyon, Rhone, France, 69373
      • Centre Leon Berard /ID# 250987
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94805
      • Institut Gustave Roussy /ID# 246824
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 231218
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 243363
  • Central District
    • Kfar Saba, Central District, Israel, 4428164
      • Meir Medical Center /ID# 244179
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center /ID# 243821
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 231217
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 245271
• Japan
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital /ID# 250290
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • NHO Nagoya Medical Center /ID# 250286
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 250284
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 232008
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 221-0855
      • Yokohama Municipal Citizen's Hospital /ID# 248842
  • Kyoto
    • Kyoto, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 250291
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital /ID# 250952
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 232007
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 248447
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital /ID# 250283
• Poland
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespó? Gru?licy i Chorób P?uc w Olsztynie /ID# 250466
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-693
      • Med Polonia Sp. z o. o. /ID# 250799
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 246569
  • Podkarpackie Voivodeship
    • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
      • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 251846
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 231580
• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 245218
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 48108
      • Inje University Haeundae Hospital /ID# 244451
  • Gyeonggido
    • Seongnam, Gyeonggido, South Korea, 13496
      • CHA Bundang Medical Center /ID# 247115
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Gyeongsang National University Hospital /ID# 248420
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital /ID# 245168
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 244667
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Kangbuk Samsung Hospital /ID# 248401
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 245215
    • Seoul, Seoul Teugbyeolsi, South Korea, 07061
      • SMG-SNU Boramae Medical Center /ID# 248421
    • Seoul, Seoul Teugbyeolsi, South Korea, 08308
      • Korea University Guro Hospital /ID# 244504
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 245374
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall de Hebron /ID# 249809
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaen /ID# 249201
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 245270
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 231464
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 248417
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 244721
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 245213
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet /ID# 244456
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 245378
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Instituto Catalan de Oncologia (ICO) Badalona /ID# 245379
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon /ID# 244505
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 248816
• Taiwan
  • Changhua City, Changhua County, Taiwan, 50006
    • Changhua Christian Hospital /ID# 249150
  • Taichung, Taiwan, 40701
    • Cmuh /Id# 245729
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 245918
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 250652
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital /ID# 245733
  • Taipei, Taiwan, 11031
    • Taipei Medical University Hospital /ID# 245732
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 248716
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 246449
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 245731
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 243841
  • Colorado
    • Aurora, Colorado, United States, 80045-2530
      • University Of Colorado Denver /ID# 231574
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine /ID# 248418
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois Hospital and Health Sciences System /ID# 251386
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338
    • Indianapolis, Indiana, United States, 46202-5112
      • Indiana University Melvin and Bren Simon Cancer Center /ID# 245133
    • Indianapolis, Indiana, United States, 46250-2042
      • Community Health Network, Inc. /ID# 245331
  • Louisiana
    • Henderson, Louisiana, United States, 89052
      • Comprehensive Cancer Centers of Nevada /ID# 242930
  • Michigan
    • Grand Rapids, Michigan, United States, 49546-7062
      • START Midwest /ID# 231551
  • New York
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute /ID# 247236
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute /ID# 231541
  • Ohio
    • Canton, Ohio, United States, 44718
      • Duplicate_Gabrail Cancer Center Research /ID# 248419
  • Texas
    • Houston, Texas, United States, 77030-4000
      • MD Anderson Cancer Center at Texas Medical Center /ID# 248656
    • Houston, Texas, United States, 77030
      • Oncology Consultants /ID# 267347
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology /ID# 231578
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists - Fairfax /ID# 231575
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties Tacoma /ID# 267339

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of malignant solid tumor (World Health Organization [WHO] criteria).
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

• For Part 2 only - advanced non-squamous squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:

  • Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR NSCLC (Part 2i) and squamous NSCLC (Part 2iii).
  • Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).
  • Must have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.

• For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on

  • If applicable, an immune checkpoint inhibitor.
  • If applicable, appropriate available therapies, including HER2-directed therapies.

Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible.

• For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:

  • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).
  • Oxaliplatin.
  • Irinotecan.
  • If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).
  • If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
  • If applicable, targeted therapy
  • Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102) or Regorafenib treated participants are eligible.
• For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.

For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options.

• Intolerant to the standard treatment are eligible

• For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on:

  • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)
  • Oxaliplatin
  • Irinotecan
  • If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab)
  • If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept)
  • If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Laboratory values meeting the criteria outlined in the protocol.

Exclusion Criteria:

• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan..
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
• History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol.
• For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 (Monotherapy Dose Escalation); Participants with advanced solid tumors will receive escalating doses of ABBV-400.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC]); Participants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 2ii (mutEGFR NSCLC); Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 2iii (Squamous NSCLC); Participants with squamous NSCLC will receive ABBV-400 at RP2D.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 5 (MET Amplification); Participants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junct; Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 4 (Colorectal Cancer); Participants with Colorectal Cancer (CRC) will receive ABBV-400 at the RP2D and various dose levels for dose optimization.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 6 (MET Mutation); Participants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization.	Drug: ABBV-400; Intravenous (IV) Infusion
Experimental: Part 7a (Combination Dose Escalation); Participants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab.	Drug: ABBV-400; Intravenous (IV) Infusion; Drug: Bevacizumab; IV Infusion
Experimental: Part 7bi (Combination Dose Optimization Low Dose); Participants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.	Drug: ABBV-400; Intravenous (IV) Infusion; Drug: Bevacizumab; IV Infusion
Experimental: Part 7bii (Combination Dose Optimization High Dose); Participants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.	Drug: ABBV-400; Intravenous (IV) Infusion; Drug: Bevacizumab; IV Infusion
Experimental: Part 7biii (Combination Comparator); Participants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab.	Drug: Bevacizumab; IV Infusion; Drug: Trifluridine/Tipiracil; Oral Tablet; Other Names: TAS-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 48 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1	DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.	Up to 48 Months
PFS per RECIST v1.1	Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.	Up to 48 Months
Overall survival (OS)	Overall survival (OS) is defined as time from first study treatment to death due to any cause.	Up to 48 Months
Parts 1-6: ORR per Independent Central Review (ICR) in Participants with MET Amplification	ORR defined as percentage of participants with confirmed best overall response of confirmed CR and PR per ICR according to RECIST version 1.1 in participants with MET amplification.	Up to 48 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Bevacizumab; Colorectal Cancer; Advanced Solid Tumors; Gastroesophageal Adenocarcinoma; TAS-102; ABBV-400; Trifluridine/Tipiracil; MET Amplification; MET Mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; trifluridine tipiracil drug combination
• Other Study ID Numbers: M21-404; 2023-509335-60-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No