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Urothelial CarcinomaPhase 1/2NCT03473743

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

A Phase 1/2 study testing Erdafitinib, Cetrelimab and Cisplatin in people with Urothelial Carcinoma, run by Janssen Research & Development, LLC at 127 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Erdafitinib, Cetrelimab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
127 sitesin 13 countries
Study dates
5 Apr 2018to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
  • Metastatic or locally advanced urothelial cancer
  • Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
  • Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

Who cannot join

  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
  • Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
  • Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
  • Active malignancies requiring concurrent therapy other than urothelial cancer
  • Symptomatic central nervous system metastases

Trial locations and contacts

127 sites in 13 countries.

127 sites in 13 countries

Spain17 sites

  • Hosp. Del Mar

    Barcelona, 08003

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28050

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Complexo Hosp. Univ. de Ourense

    Ourense, 32005

  • Complejo Hospitalario de Vigo

    Pontevedra, 36204

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • H. Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Italy15 sites

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

  • Istituto di Candiolo, IRCCS

    Candiolo, 10060

  • Ospedale Di Zona B Ramazzini

    Carpi, 41012

  • UOS Oncologia Medica, A.O. Cannizzaro

    Catania, 95126

  • Arcispedale S. Anna Ferrara

    Ferrara, 44124

  • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

    Lecco, 23900

  • Ospedale Civile Di Livorno

    Livorno, 57122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

    Perugia, 06132

  • AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

    Piacenza, 29121

  • Campus Bio Medico di Roma

    Roma, 00128

  • Azienda Socio Sanitaria Territoriale (ASST) della Valtellin

    Sondrio, 23100

  • Azienda Ospedaliera S. Maria Terni

    Terni, 05100

  • Azienda Ospedaliero Universitaria S.Maria Della Misericordia

    Udine, 33100

Other trials in Italy

Russia15 sites

  • Altai Regional Oncology Dispensary

    Barnaul, 656049

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • GUZ Kursk Regional Oncology Dispensary

    Kislino Village, 305524

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663

  • City Clinical Hospital n.a. D.D.Pletnev

    Moscow, 105077

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • Moscow City Clinical Hospital # 62

    Moscow, 125130

  • Clinical Diagnostic Centre of Nizhny Novgorod Region

    Nizhny Novgorod, 603000

  • Privolzhsky District Medical Centre

    Nizhny Novgorod, 603074

  • Clinical Oncology Dispensary

    Omsk, 644013

  • LLC Novaya Clinica

    Pyatigorsk, 357500

  • Private Medical Institution Euromedservice

    Saint Petersburg, 196603

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

  • Tambov Regional Oncology Clinical Dispansary

    Tambov, 392013

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

Other trials in Russia

United States12 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Weill Cornell Medical College - NY Presbyterian Hospital

    New York, New York, 10021

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Maryland Oncology Hematology, PA

    Rockville, Maryland, 20850

  • Toledo Clinic Cancer Centers

    Toledo, Ohio, 43623-3536

  • White Plains Hospital Center for Cancer Care

    White Plains, New York, 10601

Other trials in United States

Turkey (Türkiye)12 sites

  • Adana Acibadem Hospital

    Adana, 1130

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Hacettepe University Medical Faculty

    Ankara, 6100

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 6200

  • Adnan Menderes University Training and Research Hospital

    Aydin, 09100

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096

  • Istanbul Medeniyet University Goztepe Training and Research Hospital

    Istanbul, 34732

  • Ege University

    Izmir, 35100

  • Kocaeli University Medical Faculty

    Kocaeli

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080

Other trials in Turkey (Türkiye)

France11 sites

  • Institut de Cancerologie de Ouest (ICO) Site Paul Papin

    Angers, 49055

  • Hopital Saint André

    Bordeaux, 33075

  • Centre Francois Baclesse

    Caen, 14000

  • Centre hospitalier Saint Louis

    La Rochelle, 17019

  • Centre Leon Berard

    Lyon, 69008

  • APHM Hopital Timone

    Marseille, 13005

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Clinique Sainte Anne

    Strasbourg, 67000

  • CHRU de Tours

    Tours, 37044

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

South Korea10 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hospital

    Gwangju, 61469

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Belarus7 sites

  • Brest Regional Oncology Dispensary

    Brest, 224027

  • Grodno University Hospital

    Grodno, 230017

  • Gomel Regional Clinical Oncology Dispensary

    Homyel, 246012

  • State Institution N.N. Alexandrov Republican Scientific and

    Lesnoy, 223040

  • Minsk city Clinical Oncological Dispensary

    Minsk, 220013

  • Mogilev Regional Hospital

    Mogilev, 212018

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210603

Other trials in Belarus

Belgium7 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Jolimont

    Haine-Saint-Paul, 7100

  • Az Groeninge

    Kortrijk, 8500

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

  • AZ Nikolaas - Campus Sint-Niklaas Moerland

    Sint-Niklaas, 9100

  • GZA Ziekenhuizen- Campus St Augustinus

    Wilrijk, 2610

Other trials in Belgium

Brazil7 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060

  • Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro

    Fortaleza, 60170-170

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

Other trials in Brazil

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333

Other trials in Taiwan

Poland4 sites

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513

  • LUX MED Onkologia Sp. z o.o.

    Warsaw, 01-748

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

Other trials in Poland

United Kingdom4 sites

  • Royal Lancaster Infirmary

    Lancaster, LA1 4rp

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

About this study

Official title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

Read the detailed description

This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.

Being tested
Erdafitinib, Cetrelimab, Cisplatin, Carboplatin
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErdafitinibDrug

    Also called JNJ-42756493

    Participants will receive erdafitinib orally.

  • CetrelimabDrug

    Also called JNJ-63723283

    Participants will receive cetrelimab by intravenous infusion.

  • CisplatinDrug

    Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.

  • CarboplatinDrug

    Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.

Study groups in NCT03473743
Study groupRoleWhat they receive
Phase 1b: Dose EscalationExperimentalTwo dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Receives: Drug: Erdafitinib; Drug: Cetrelimab; Drug: Cisplatin; Drug: Carboplatin
Phase 2: Dose ExpansionExperimentalThe participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Receives: Drug: Erdafitinib; Drug: Cetrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)

    Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.

    Measured: Up to 8 weeks

  2. Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment

    ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.

    Measured: From Day 1 up to 36 months

  3. Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)

    Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.

    Measured: From Day 1 up to 36 months

Secondary outcomes (10)

  1. Phase 1b and Phase 2: Plasma Concentration of Erdafitinib

    Measured: Up to 6 years 1 month

  2. Phase 1b and Phase 2: Serum Concentration of Cetrelimab

    Measured: Up to 6 years 1 month

  3. Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy

    Measured: Up to 6 years 1 month

  4. Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies

    Measured: Up to 6 years 1 month

  5. Phase 2: Number of Participants With Serious Adverse Events (SAEs)

    Measured: Up to 6 years 1 month

  6. Phase 2: Number of Participants With Abnormal Laboratory Values

    Measured: Up to 6 years 1 month

  7. Phase 2: Duration of Response (DoR)

    Measured: Up to 6 years 1 month

  8. Phase 2: Time to Response (TTR)

    Measured: Up to 6 years 1 month

  9. Phase 2: Progression-free Survival (PFS)

    Measured: Up to 6 years 1 month

  10. Phase 2: Overall Survival (OS)

    Measured: Up to 6 years 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start5 Apr 2018
  3. Primary completion30 Sep 2022
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473743
Sponsor's protocol ID
CR108445
Other IDs
42756493BLC2002, 2017-001980-19, 2023-510295-31-00, 2023, 2017
Status last verified
Aug 2026
First submitted
14 Mar 2018
Last updated
28 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Loriot Y, Powles T, Moreno V, Kang TW, Cicin I, Girvin A, Akapame S, O'Hagan A, Zhu W, Tammaro M, Thomas S, Triantos S, Siefker-Radtke AO. Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study. J Clin Oncol. 2026 Mar 10;44(8):676-684. doi: 10.1200/JCO-25-00826. Epub 2026 Jan 15.

    PubMed 41538748

  • LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

    PubMed 39971605

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Erdafitinib, Cetrelimab and Cisplatin in people with Urothelial Carcinoma, run by Janssen Research & Development, LLC at 127 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Spain, Italy, Russia, United States, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs) (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473743, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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