Non-Hodgkin LymphomaPhase 1NCT05169515
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
A Phase 1 study testing SC Mosunetuzumab, IV Glofitamab and Iberdomide in people with Non-Hodgkin Lymphoma, run by Hoffmann-La Roche at 25 sites in 5 countries.
Trial summary
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- SC Mosunetuzumab, IV Glofitamab and Iberdomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 26 Oct 2022to 5 Aug 2029
- Phase
- Phase 1
- 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
- Age >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBCL/transformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen.
- Participants with DLBCL/transformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol
- Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)
- At least one bi-dimensionally measurable nodal lesion (> 1.5 cm in its largest dimension by diagnostic quality CT or PET/CT scan), or at least one bi-dimensionally measurable extranodal lesion (> 1.0 cm in its largest dimension by diagnostic quality CT or PET/CT scan)
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- Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of NHL
- A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred
- Adequate hematologic function without growth factors or blood product transfusion within 14 days of first dose of study drug administration
- Normal laboratory values
- All participants and health care providers will be trained and counseled on pregnancy prevention. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 3 months after the final dose of mosunetuzumab, at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC-99282, 3 months after the last dose of tocilizumab (if applicable), whichever is longer
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer
Who cannot join
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment) or within 3 months after the final dose of mosunetuzumab, at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, whichever is longer, 28 days after the last dose of CC-220, 28 days after the last dose of CC-9282, 3 months after the final dose of tocilizumab, whichever is longer
- Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122, pomalidomide) </= 4 weeks prior to starting CC-220 and/or CC-99282
- Inability to swallow pills, or persistent diarrhea or malabsorption >= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management
- QTc interval of > 470 ms
- The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation
- Treatments (investigational or approved) within the following time periods prior to initiation/first dose of study treatment: radiotherapy within 2 weeks; autologous SCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days; prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugates within 4 weeks; use of radioimmunoconjugates within 12 weeks; systemic immunosuppressive medications within 2 weeks; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter
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- Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment
- Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- 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, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Major surgery or significant traumatic injury < 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per US national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0) prior to the first study drug administration with exceptions defined by the protocol
- Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary, liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliance with the protocol or interpretation of results
- For participants enrolled into glofitamab cohort: documented refractoriness to an obinutuzumab monotherapy-containing regimen (defined as disease that did not achieve response (PR or CR) or progressed within 6 months of the last dose of an obinutuzumab-containing regimen)
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States6 sites
University of Colorado
Aurora, Colorado, 80045
Levine Cancer Institute
Charlotte, North Carolina, 28204
The University of Chicago
Chicago, Illinois, 60637
UT MD Anderson Cancer Center
Houston, Texas, 77030
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33612
Spain6 sites
Hospital Universitari Vall d Hebron
Barcelona, 08035
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Clinica Universidad de Navarra-Madrid
Madrid, 28027
Hospital General Universitario Gregorio Maranon
Madrid, 28040
Hosp Universitario Salamanca
Salamanca, 37007
Hospital Universitario La Fe
Valencia, Valencia, 46026
Israel5 sites
Soroka
Beersheba, 0084101
Rambam Health Care Campus
Haifa, 3109600
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
Center Hospital
Ramat Gan, 5262199
Sourasky Medical Center
Tel Aviv, 6423900
Italy4 sites
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, 47014
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa, Piedmont, 56126
United Kingdom4 sites
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
University College London Hospitals
London, W1T 7HA
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- SC Mosunetuzumab, IV Glofitamab, Iberdomide, Golcadomide, Obinutuzumab
- 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.
SC MosunetuzumabDrug
Also called RO7030816
Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12)
IV GlofitamabDrug
Also called RO7082859
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
IberdomideDrug
Also called CC-220
Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
GolcadomideDrug
Also called CC-99282
Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days)
ObinutuzumabDrug
Also called RO5072759
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
TocilizumabDrug
Also called RO4877533
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282. Receives: Drug: SC Mosunetuzumab; Drug: Iberdomide; Drug: Golcadomide; Drug: Tocilizumab |
| Arm 2 | Experimental | Participants will receive intravenous (IV) glofitamab + CC-99282. Receives: Drug: IV Glofitamab; Drug: Golcadomide; Drug: Obinutuzumab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Measured: Until 90 days after the final dose of study treatment
Percentage of participants with adverse events [all cohorts]
Measured: Until 90 days after the final dose of study treatment
Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]
Measured: Up to 2 years after start of primary study treatment
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose escalation]
Measured: Until 90 days after the final dose of study treatment
Secondary outcomes (11)
Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts]
Measured: Up to 1 year after primary study treatment
Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation]
Measured: Up to 2 years after primary study treatment
Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts]
Measured: Up to 2 years after primary study treatment
Progression-free survival (PFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Measured: Up to 2 years after primary study treatment
Event-free survival (EFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Measured: Up to 2 years after primary study treatment
Overall survival (OS) [dose expansion]
Measured: Up to 2 years after primary study treatment
Percentage of participants with adverse events [dose expansion]
Measured: Until 90 days after the final dose of study treatment
Serum concentration of subcutaneous (SC) mosunetuzumab [all cohorts]
Measured: Up to 2 years after primary study treatment
Serum concentration of intravenous (IV) glofitamab [all cohorts]
Measured: Up to 2 years after primary study treatment
Serum concentration of CC-220 and CC-99282 (CELMoDs) [all cohorts]
Measured: Up to 12 cycles of study treatment (cycle length = 21 or 28 days for Arm 1 and 21 days for Arm 2)
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose expansion]
Measured: Until 90 days after the final dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start26 Oct 2022
- Primary completion5 Aug 2029 (estimated)
- Study completion5 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169515
- Sponsor's protocol ID
- CO43805
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05169515
- Acronym / sponsor ID
- CO43805
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 5 Aug 2029 (estimated)
- Study completion
- 5 Aug 2029 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SC Mosunetuzumab, Drug: Iberdomide, Drug: Golcadomide, Drug: TocilizumabParticipants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282. |
| Arm 2 | Experimental | Drug: IV Glofitamab, Drug: Golcadomide, Drug: Obinutuzumab, Drug: TocilizumabParticipants will receive intravenous (IV) glofitamab + CC-99282. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBCL/transformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen.
- Participants with DLBCL/transformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol
- Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)
Key exclusion criteria (14 listed)
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment) or within 3 months after the final dose of mosunetuzumab, at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, whichever is longer, 28 days after the last dose of CC-220, 28 days after the last dose of CC-9282, 3 months after the final dose of tocilizumab, whichever is longer
- Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122, pomalidomide) </= 4 weeks prior to starting CC-220 and/or CC-99282
- Inability to swallow pills, or persistent diarrhea or malabsorption >= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management
- QTc interval of > 470 ms
- The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC MosunetuzumabAlso: RO7030816Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12) | Drug | Arm 1 |
| IV GlofitamabAlso: RO7082859Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days) | Drug | Arm 2 |
| IberdomideAlso: CC-220Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12) | Drug | Arm 1 |
| GolcadomideAlso: CC-99282Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days) | Drug | Arm 1, Arm 2 |
| ObinutuzumabAlso: RO5072759Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days) | Drug | Arm 2 |
| TocilizumabAlso: RO4877533Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) | Drug | Arm 1, Arm 2 |
Primary outcome
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Time frame: Until 90 days after the final dose of study treatment
Percentage of participants with adverse events [all cohorts]
Time frame: Until 90 days after the final dose of study treatment
Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]
Time frame: Up to 2 years after start of primary study treatment
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose escalation]
Time frame: Until 90 days after the final dose of study treatment
11 secondary outcomes
Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts]
Time frame: Up to 1 year after primary study treatment
Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation]
Time frame: Up to 2 years after primary study treatment
Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts]
Time frame: Up to 2 years after primary study treatment
Progression-free survival (PFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Time frame: Up to 2 years after primary study treatment
Event-free survival (EFS) as determined by the investigator using Lugano 2014 criteria [dose expansion]
Time frame: Up to 2 years after primary study treatment
Overall survival (OS) [dose expansion]
Time frame: Up to 2 years after primary study treatment
Percentage of participants with adverse events [dose expansion]
Time frame: Until 90 days after the final dose of study treatment
Serum concentration of subcutaneous (SC) mosunetuzumab [all cohorts]
Time frame: Up to 2 years after primary study treatment
Serum concentration of intravenous (IV) glofitamab [all cohorts]
Time frame: Up to 2 years after primary study treatment
Serum concentration of CC-220 and CC-99282 (CELMoDs) [all cohorts]
Time frame: Up to 12 cycles of study treatment (cycle length = 21 or 28 days for Arm 1 and 21 days for Arm 2)
Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose expansion]
Time frame: Until 90 days after the final dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC Mosunetuzumab, IV Glofitamab and Iberdomide in people with Non-Hodgkin Lymphoma, run by Hoffmann-La Roche at 25 sites in 5 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 12 inclusion and 14 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 17 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 25 sites in United States, Spain, Israel, Italy, United Kingdom. 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 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.
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?
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation] (time frame: Until 90 days after the final dose of study treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.