Cutaneous MelanomaPhase 1NCT04551352
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas
A Phase 1 study testing RO7293583, Tocilizumab and Obinutuzumab in people with Cutaneous Melanoma and Uveal Melanoma, run by Hoffmann-La Roche at 14 sites in 6 countries.
Trial summary
This is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma, Uveal Melanoma, Mucosal Melanoma
- What is being tested?
- RO7293583, Tocilizumab and Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 28 Oct 2020to 28 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants with unresectable stage III or stage IV cutaneous melanoma or participants with unresectable, metastatic uveal or mucosal melanoma for whom SOC is not available or who are intolerant or non-amenable to SOC.
- Participants with cutaneous melanoma need to have known BRAF status.
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Availability of a representative tumor specimen that is suitable for determination of TYRP1 status by means of central testing.
- For participants in Part II, willingness to provide mandatory on-treatment biopsies.
- Life expectancy (in the opinion of the Investigator) of ≥12 weeks.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Absence of rapid disease progression, threat to vital organs or non-irradiated lesions > 2 cm in diameter at critical sites.
- All acute toxic effects of any prior radiotherapy, chemotherapy, targeted or checkpoint inhibitor therapy, or surgical procedure must have resolved to Grade ≤1 or returned to baseline, except for alopecia (any grade), for Grade 2 clinically controlled sequelae of immune-related toxicities related to checkpoint inhibitor therapy like adrenal insufficiency and hypopituitarism, and for Grade 2 peripheral neuropathy.
- Adequate hematological, liver and renal function.
Who cannot join
- Participants with a history or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening.
- Participants with another invasive malignancy in the last 2 years.
- Active, acute, or chronic inflammatory diseases of the skin affecting more than 5% of the body surface area. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms.
- Participants with defects in the Bruch's membrane of the eye or at risk of such defects. Participants with a history of recurrent uveitis or medical conditions that are associated with frequent uveitis.
- History of or existing damage to inner ear.
- Uncontrolled hypertension.
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- Significant cardiovascular disease.
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to the start of drug administration.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
- Major surgery or significant traumatic injury <28 days prior to the first RO7293583 administration or anticipation of the need for major surgery during study treatment.
- Last dose of checkpoint inhibitors, targeted therapies, chemotherapy, immunostimulating or immunosuppressive therapy or other investigational drug <28 days prior to the first RO7293583 administration.
- Prior treatment with a T-cell engaging drug
- Specific Exclusion Criteria if Pre-treatment with Obinutuzumab is Implemented:
- Known human immunodeficiency virus (HIV)
- History of progressive multifocal leukoencephalopathy.
- Active Tuberculosis (TB) requiring treatment within 3 years prior to baseline.
- Latent TB diagnosed during Screening.
- Positive test results for human T-lymphotropic virus 1.
- Specific Exclusion Criteria if Pre-treatment with Adalimumab is Implemented:
- History of untreated tuberculosis or untreated active infection with mycobacterium tuberculosis.
- Known hypersensitivity to any of the components of adalimumab.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University Hospital;Medical Oncology
Philadelphia, Pennsylvania, 19107
Spain4 sites
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Canada2 sites
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5
Australia1 site
Peter Maccallum Cancer Institute; Clinical Trial Unit
Melbourne, Victoria, 3000
About this study
Official title: An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma
This is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care (SOC) treatment, are intolerant to SOC, or are non-amenable to SOC. This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion.
- Conditions
- Cutaneous Melanoma, Uveal Melanoma, Mucosal Melanoma
- Being tested
- RO7293583, Tocilizumab, Obinutuzumab, Adalimumab
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7293583Drug
RO7293583 will be administered at a dose and per schedule as specified for the respective cohort.
TocilizumabDrug
Also called Actemra
Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS).
ObinutuzumabDrug
Also called Gazyva
If implemented, it will be given either on D-7 or D-7 and D-6.
AdalimumabDrug
Also called Humira
If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583.
| Study group | Role | What they receive |
|---|---|---|
| Part I: Single Participant Cohorts (IV) | Experimental | Part I is a dose escalation in single participant cohorts. RO7293583 will be administered intravenously (IV) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg. Receives: Drug: RO7293583; Drug: Tocilizumab |
| Part II: Multiple Participant Cohorts (IV/SC) | Experimental | Multiple ascending dose-escalation of RO7293583 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered IV or SC every 3 weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC. Receives: Drug: RO7293583; Drug: Tocilizumab; Drug: Obinutuzumab; Drug: Adalimumab |
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-Limiting Toxicities (DLTs) were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), except for Cytokine release syndrome (CRS), which will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: From Day 1 of Cycle 1 up to Day 1 of Cycle 3 (each cycle is 21 days)
Percentage of Participants with Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Baseline up to 60 days after last RO7293583 treatment (up to 14 months)
Secondary outcomes (14)
Maximum Concentration (Cmax) of RO7293583
Measured: Up to 14 months
Time of Maximum Concentration (Tmax) of RO7293583
Measured: Up to 14 months
Minimum Concentration (Cmin) of RO7293583
Measured: Up to 14 months
SC Bioavailability (F) of RO7293583
Measured: Up to 14 months
Clearance (CL) or Apparent Clearance (CL/F) of RO7293583
Measured: Up to 14 months
Volume of Distribution at Steady State (Vss) of RO7293583
Measured: Up to 14 months
Area Under the Curve (AUC) of RO7293583
Measured: Up to 14 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7293583
Measured: From baseline until 60 days after last RO7293583 dose (up to 14 months).
Change from Baseline in RO7293583 ADA Titer
Measured: From baseline until 60 days after last RO7293583 dose (up to 14 months).
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Baseline up to 13 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with CR, PR, or stable disease (SD). Per RECIST v1.1, CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.
Measured: Baseline up to 13 months
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of documented OR to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Baseline up to 13 months
Progression-Free Survival (PFS)
PFS is defined as the time from Cycle 1, Day 1 to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Baseline up to 24 months.
Overall Survival (OS)
OS is defined as the time from Cycle 1, Day 1 to death from any cause.
Measured: Baseline up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start28 Oct 2020
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous MelanomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT04551352
- Sponsor's protocol ID
- BP42169
- Other IDs
- 2020-000793-18
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spreafico A, Couselo EM, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane IM, Sanmamed MF, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umana P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack RF, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Front Oncol. 2024 Mar 21;14:1346502. doi: 10.3389/fonc.2024.1346502. eCollection 2024.
PubMed 38577337
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04551352
- Acronym / sponsor ID
- BP42169
- Conditions
- Cutaneous Melanoma, Uveal Melanoma, Mucosal Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 16 Sep 2020 (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 is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care (SOC) treatment, are intolerant to SOC, or are non-amenable to SOC. This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I: Single Participant Cohorts (IV) | Experimental | Drug: RO7293583, Drug: TocilizumabPart I is a dose escalation in single participant cohorts. RO7293583 will be administered intravenously (IV) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg. |
| Part II: Multiple Participant Cohorts (IV/SC) | Experimental | Drug: RO7293583, Drug: Tocilizumab, Drug: Obinutuzumab, Drug: AdalimumabMultiple ascending dose-escalation of RO7293583 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered IV or SC every 3 weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants with unresectable stage III or stage IV cutaneous melanoma or participants with unresectable, metastatic uveal or mucosal melanoma for whom SOC is not available or who are intolerant or non-amenable to SOC.
- Participants with cutaneous melanoma need to have known BRAF status.
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Availability of a representative tumor specimen that is suitable for determination of TYRP1 status by means of central testing.
- For participants in Part II, willingness to provide mandatory on-treatment biopsies.
Key exclusion criteria (21 listed)
- Participants with a history or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening.
- Participants with another invasive malignancy in the last 2 years.
- Active, acute, or chronic inflammatory diseases of the skin affecting more than 5% of the body surface area. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms.
- Participants with defects in the Bruch's membrane of the eye or at risk of such defects. Participants with a history of recurrent uveitis or medical conditions that are associated with frequent uveitis.
- History of or existing damage to inner ear.
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 |
|---|---|---|
| RO7293583RO7293583 will be administered at a dose and per schedule as specified for the respective cohort. | Drug | Part I: Single Participant Cohorts (IV), Part II: Multiple Participant Cohorts (IV/SC) |
| TocilizumabAlso: ActemraTocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). | Drug | Part I: Single Participant Cohorts (IV), Part II: Multiple Participant Cohorts (IV/SC) |
| ObinutuzumabAlso: GazyvaIf implemented, it will be given either on D-7 or D-7 and D-6. | Drug | Part II: Multiple Participant Cohorts (IV/SC) |
| AdalimumabAlso: HumiraIf implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583. | Drug | Part II: Multiple Participant Cohorts (IV/SC) |
Primary outcome
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 of Cycle 1 up to Day 1 of Cycle 3 (each cycle is 21 days)
Dose-Limiting Toxicities (DLTs) were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), except for Cytokine release syndrome (CRS), which will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to 60 days after last RO7293583 treatment (up to 14 months)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
14 secondary outcomes
Maximum Concentration (Cmax) of RO7293583
Time frame: Up to 14 months
Time of Maximum Concentration (Tmax) of RO7293583
Time frame: Up to 14 months
Minimum Concentration (Cmin) of RO7293583
Time frame: Up to 14 months
SC Bioavailability (F) of RO7293583
Time frame: Up to 14 months
Clearance (CL) or Apparent Clearance (CL/F) of RO7293583
Time frame: Up to 14 months
Volume of Distribution at Steady State (Vss) of RO7293583
Time frame: Up to 14 months
Area Under the Curve (AUC) of RO7293583
Time frame: Up to 14 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7293583
Time frame: From baseline until 60 days after last RO7293583 dose (up to 14 months).
Change from Baseline in RO7293583 ADA Titer
Time frame: From baseline until 60 days after last RO7293583 dose (up to 14 months).
Objective Response Rate (ORR)
Time frame: Baseline up to 13 months
Disease Control Rate (DCR)
Time frame: Baseline up to 13 months
Duration of Response (DOR)
Time frame: Baseline up to 13 months
Progression-Free Survival (PFS)
Time frame: Baseline up to 24 months.
Overall Survival (OS)
Time frame: Baseline up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 38577337Spreafico A, Couselo EM, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane IM, Sanmamed MF, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umana P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack RF, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Front Oncol. 2024 Mar 21;14:1346502. doi: 10.3389/fonc.2024.1346502. eCollection 2024.
- 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
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7293583, Tocilizumab and Obinutuzumab in people with Cutaneous Melanoma and Uveal Melanoma, run by Hoffmann-La Roche at 14 sites in 6 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 21 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: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, Belgium, Canada, Australia and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: From Day 1 of Cycle 1 up to Day 1 of Cycle 3 (each cycle is 21 days)). The study lists 2 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 NCT04551352, which also lists 1 linked publication.
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 3 Oct 2022.