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Non-Hodgkin's LymphomaPhase 1/2NCT03075696

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

A Phase 1/2 study testing Glofitamab, Obinutuzumab and Tocilizumab in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 34 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

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Glofitamab, Obinutuzumab and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
940 participants
Where
34 sitesin 13 countries
Study dates
21 Feb 2017to 30 Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [ASCT])
  • Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
  • Able to provide a tumor tissue pretreatment biopsy at last relapse or during screening from a safely accessible site, per investigator determination, providing the patient has more than one measurable target lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of >/=12 weeks
  • AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to (</=) 1
Show all 10Show fewer
  • Adequate liver, hematological and renal function
  • Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
  • Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal (at least 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test

Who cannot join

  • Inability to comply with protocol mandated hospitalizations and restrictions
  • Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
  • Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
  • Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
  • Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA4], anti-programmed death 1 [anti-PD1] and anti-programmed death ligand 1 [anti-PDL1]) within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on Cycle 1 Day -7
Show all 23Show fewer
  • History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents
  • Documented refractoriness to an obinutuzumab-containing regimen
  • Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent, including chimeric antigen receptor therapy (CAR-T) within 4 weeks prior to obinutuzumab infusion
  • Prior solid organ transplantation
  • Prior allogeneic stem cell transplantation (SCT)
  • Autologous SCT within 100 days prior to obinutuzumab infusion
  • Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)
  • Current or past history of central nervous system (CNS) lymphoma
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
  • Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
  • Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
  • Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study
  • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to obinutuzumab infusion. Treatment with corticosteroid </= 25 mg/day prednisone or equivalent is allowed. Inhaled and topical steroids are permitted
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
  • History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus, erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Participants with a remote history of, or well controlled autoimmune disease, may be eligible to enroll after consultation with the Medical Monitor
  • In Part III diffuse large B-cell lymphoma (DLBCL) dexamethasone cohort, participants with a history of hypersensitivity to dexamethasone or systemic corticosteroids will be excluded

Trial locations and contacts

34 sites in 13 countries.

34 sites in 13 countries

United States6 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0934

  • Mount Sinai Medical Center

    New York, New York, 10029

  • MSKCC

    New York, New York, 10065

  • Allegheny Health Network (Pittsburg PA)

    Pittsburgh, Pennsylvania, 15212

  • Swedish Cancer Inst.

    Seattle, Washington, 98104

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Spain6 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08915

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Univ. 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

France5 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital Claude Huriez

    Lille, 59037

  • CHU Saint Eloi

    Montpellier, 34295

  • Ch Lyon Sud

    Pierre-Bénite, 69495

  • CHU DE RENNES - CHU Pontchaillou

    Rennes, 35033

Other trials in France

Italy3 sites

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133

  • AUSL della Romagna

    Ravenna, Emilia-Romagna, 48121

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367

Other trials in Poland

Australia2 sites

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Taiwan2 sites

  • China Medical University Hospital

    Taichung, 404

  • National Taiwan Universtiy Hospital

    Taipei, 100

Other trials in Taiwan

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Czechia1 site

  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

    Prague, 128 08

Other trials in Czechia

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00029

Other trials in Finland

New Zealand1 site

  • Auckland Cancer Trial Centre

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

Being tested
Glofitamab, Obinutuzumab, Tocilizumab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • GlofitamabDrug

    Also called RO7082859

    Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.

  • ObinutuzumabDrug

    Also called RO5072759, GA101, Gazyva®, Gazyvaro™

    Obinutuzumab 1000 mg single dose IV infusion on Day -7; or 2000 mg single dose administered on Day -7, or split into two 1000 mg doses administered on Days -1 and -7, and per the schedule specified in the respective arms.

  • TocilizumabDrug

    Also called Actemra®, Roactemra®

    Tocilizumab will be administered as an IV infusion, if required, for the management of severe Cytokine Release Syndrome (CRS) occurring during or after any infusion of glofitamab, as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents.

Study groups in NCT03075696
Study groupRoleWhat they receive
Part I: Dose EscalationExperimentalParticipants (single participant cohorts) will receive obinutuzumab pretreatment (Gpt) 1000 milligrams (mg) single dose IV infusion on Day -7 followed by glofitamab IV infusion on Day 1 and Day 8 of Cycle 1. From Cycle 2 onwards, ascending doses of glofitamab will be administered on Day 1 of every 2 week (Q2W) cycle up to Cycle 12 (24 weeks) or until unacceptable toxicity or disease progression. Glofitamab dosing will be initiated at 5 micrograms (mcg) (flat dose) followed by doses of 15 mcg, 45 mcg, 135 mcg, 405 mcg and 810 mcg.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab
Part II: Dose EscalationExperimentalIn each treatment regimen, participants will receive Gpt 1000 mg IV infusion on Day -7; or 2000 mg either administered on Day -7, or split into two 1000 mg doses on Days -1 and -7. The first glofitamab IV infusion will be given on Day 1 of Cycle 1 and a total of 12 cycles will be administered. Monotherapy, glofitamab as a single agent: ascending doses of glofitamab administered on Day 1 of Q2W or every 3 week (Q3W) cycle until either the MTD/OBD is defined. Combination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with ascending doses of glofitamab on Day 1 of Q3W cycle until either the MTD/OBD is defined. Step-up dosing: Q3W, participants will receive an initial low dose of glofitamab on Cycle 1 Day 1, followed by a higher dose on Cycle 1 Day 8; the total dose in Cycle 1 will not exceed the previously determined MTD. Higher doses may be explored from Cycle 2 or later cycles.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab
Part III: Dose ExpansionExperimentalPart III will start once MTD/OBD is defined. Participants will receive Gpt 1000 mg single dose IV infusion on Day -7, followed by glofitamab at a fixed dose regimen or step-up dose regimen on a Q2W or Q3W dosing schedule as determined in Part II. A total of 12 cycles will be administered. Combination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with glofitamab at the dosing regimen determined in Part II.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab

What is being measured

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

  1. Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs)

    Measured: From Baseline up to 4 weeks

  2. Part I, II and III: Percentage of Participants With Adverse Events (AEs)

    Measured: From Baseline up to 90 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)

  3. Part II: MTD or OBD of Glofitamab

    Measured: From Baseline up to 4 weeks

  4. Part II: Recommended Phase II Dose (RP2D) of Glofitamab

    Measured: From Baseline up to 5 years

  5. Part III: Complete Response (CR) Rate as Assessed by Independent Review Committee (IRC) According to Standard Non-hodgkin's Lymphoma (NHL) Response Criteria (Lugano Classification)

    Measured: From treatment start up to 5 years

  6. Part I, II and III: Area Under the Serum Concentration Versus Time Curve (AUC) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 to Day 71

  7. Part I, II and III: Maximum Serum Concentration (Cmax) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 to Day 198

  8. Part I, II and III: Minimum Serum Concentration (Cmin) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 up to Day 198

  9. Part I, II and III: Clearance (CL) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 to Day 71

  10. Part I, II and III: Volume of Distribution at Steady-state (Vss) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 to Day 71

  11. Part I, II and III: Half-life (t1/2) of Glofitamab

    Measured: At pre-defined intervals from Cycle 1 Day 1 to Day 71

Secondary outcomes (13)

  1. Part I, II and III: Cmax of Obinutuzumab

    Measured: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of Cycle 1

  2. Part I, II and III: Cmin of Obinutuzumab

    Measured: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of Cycle 1

  3. Part I, II and III: Anti-drug Antibodies (ADA) to Glofitamab

    Measured: Pre-dose of obinutuzumab on Day -7; pre-dose (Hr 0) of glofitamab on Day 1 of each cycle from Cycle 2 onwards for a maximum of 8-12 cycles, and at EOT/follow-up visit (up to 5 years)

  4. Parts I and II: Percentage of Participants With Overall Response (Partial Response [PR] or Complete Response [CR]) as Determined by the Lugano Classification

    Measured: From Baseline up to end of study or discontinuation due to disease progression (up to 5 years)

  5. Part I, II and III: Percentage of Participants With PR or CR (Overall Response Rate [ORR]) as Determined by the Lugano Classifications

    Measured: From Baseline up to end of study or discontinuation due to disease progression (up to 5 years)

  6. Part I, II and III: Duration of Response (DOR) as Determined by the Lugano Classification

    Measured: From first occurrence of documented objective response until disease progression, relapse or death due to any cause (up to 5 years)

  7. Part I, II and III: Duration of Complete Response (DOCR) as Determined by the Lugano Classification

    Measured: From the first occurrence of a documented, complete response, until the time of relapse or death from any cause (up to 5 years)

  8. Part I, II and III: Progression-Free Survival (PFS) as Determined by the Lugano Classification

    Measured: From first study treatment to the first occurrence of disease progression or death due to any cause (up to 5 years)

  9. Overall Survival (OS)

    Measured: From the time of first study treatment to death from any cause (up to 5 years)

  10. Time to First Overall Response (TFOR)

    Measured: From time of treatment start to first documented response (up to 5 years)

  11. Time to First Complete Response (TFCR)

    Measured: From treatment start to first documented complete response (up to 5 years)

  12. Part III: Health Related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30)

    Measured: From baseline through follow-up or until disease progression (up to 5 years)

  13. Part III: HRQoL as Assessed by the Functional Assessment of Cancer Therapy-lymphoma (FACT-lym) Scale

    Measured: From baseline through follow-up or until disease progression (up to 5 years)

Timeline

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

  1. First posted9 Mar 2017
  2. Study start21 Feb 2017
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion30 Mar 2029 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
940 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075696
Sponsor's protocol ID
NP30179
Other IDs
2016-001185-28, 2023-505625-14-00, 2023, 2016
Status last verified
Oct 2026
First submitted
7 Mar 2017
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Phillips TJ, Carlo-Stella C, Morschhauser F, Bachy E, Crump M, Trneny M, Bartlett NL, Zaucha J, Wrobel T, Offner F, Humphrey K, Relf J, Filezac de L'Etang A, Carlile DJ, Byrne B, Qayum N, Lundberg L, Dickinson M. Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study. J Clin Oncol. 2025 Jan 20;43(3):318-328. doi: 10.1200/JCO.23.02470. Epub 2024 Oct 4.

    PubMed 39365960

  • Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11.

    PubMed 36507690

  • Frances N, Bacac M, Bray-French K, Christen F, Hinton H, Husar E, Quackenbush E, Schafer M, Schick E, Vyver AV, Richter WF. Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. J Pharm Sci. 2022 Apr;111(4):1208-1218. doi: 10.1016/j.xphs.2021.12.019. Epub 2021 Dec 22.

    PubMed 34953862

  • Broske AE, Korfi K, Belousov A, Wilson S, Ooi CH, Bolen CR, Canamero M, Alcaide EG, James I, Piccione EC, Carlile DJ, Dimier N, Umana P, Bacac M, Weisser M, Dickinson M. Pharmacodynamics and molecular correlates of response to glofitamab in relapsed/refractory non-Hodgkin lymphoma. Blood Adv. 2022 Feb 8;6(3):1025-1037. doi: 10.1182/bloodadvances.2021005954.

    PubMed 34941996

  • Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, Salles G, Martinez-Lopez J, Crump M, Thomas DN, Morcos PN, Ferlini C, Broske AE, Belousov A, Bacac M, Dimier N, Carlile DJ, Lundberg L, Perez-Callejo D, Umana P, Moore T, Weisser M, Dickinson MJ. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959-1970. doi: 10.1200/JCO.20.03175. Epub 2021 Mar 19.

    PubMed 33739857

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Glofitamab, Obinutuzumab and Tocilizumab in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 34 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 10 inclusion and 23 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Spain, France, Italy, Poland 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?

This study is still under way. Results are not available in the source record yet.

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?

Part I and II: Percentage of Participants With Dose Limiting Toxicities (DLTs) (time frame: From Baseline up to 4 weeks). The study lists 11 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 NCT03075696, which also lists 5 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 Oct 2026.

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