Solid Tumor, Unspecified, AdultPhase 1NCT03628677
A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies
A Phase 1 study testing Domvanalimab and Zimberelimab in people with Solid Tumor, Unspecified, Adult, run by Arcus Biosciences, Inc. at 10 sites in 2 countries.
Trial summary
This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Unspecified, Adult
- What is being tested?
- Domvanalimab and Zimberelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Sep 2018to 23 Jan 2025
- 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
- Capable of giving signed informed consent
- Male or female participants ≥ 18 years of age at the time of screening
- Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1; negative serum or urine pregnancy test on the first day of each subsequent treatment period
- Participants with any pathologically confirmed solid tumor type for which no standard of care therapy exists
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 7. Confirmation that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor must be obtained 8. Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids ≤ 10 mg/day of prednisone or its equivalent may be permitted
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- Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration
- Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
- Adequate organ and marrow function
Who cannot join
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of domvanalimab as monotherapy and in combination with zimberelimab.
- Participants who require a Legally Authorized Representative (LAR) to provide informed consent on their behalf.
- Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
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- Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
- Has had prior chemotherapy, targeted small-molecule therapy, immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer), biologic agents or radiation therapy within 4 weeks (or 5 half-lives) prior to Day 1 or has not recovered from AEs due to a previously administered agent
- Use of other investigational drugs within 28 days or at least 5 half-lives before investigational product administration.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Affinity Health-Hope and Healing Cancer Services, LLC
Hinsdale, Illinois, 60521
MD Anderson Cancer Center
Houston, Texas, 77030
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
START
San Antonio, Texas, 78229
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, 99208
Australia4 sites
The Kinghorn Cancer Centre - St Vincent Public Hospital
Darlinghurst, New South Wales, 2010
Olivia Newton-John Cancer Research Institute-Austin Hostipal
Heidelberg, Victoria, 3084
Icon Cancer Care Brisbane
South Brisbane, Queensland, 4101
Tweed Hospital
Tweed Heads, New South Wales, 2486
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.
- Conditions
- Solid Tumor, Unspecified, Adult
- Being tested
- Domvanalimab, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomvanalimabDrug
Also called AB154
Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT
ZimberelimabDrug
Also called AB122
Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1
| Study group | Role | What they receive |
|---|---|---|
| Domvanalimab Monotherapy | Experimental | Varying Doses of domvanalimab Monotherapy Receives: Drug: Domvanalimab |
| Domvanalimab + zimberelimab Q2W Combination Therapy | Experimental | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Domvanalimab + zimberelimab Q3W Combination Therapy | Experimental | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Domvanalimab + zimberelimab Q4W Combination Therapy | Experimental | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Domvanalimab and Zimberelimab Q6W combination therapy | Experimental | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W | Experimental | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab Receives: Drug: Domvanalimab; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Number of Participants Treated with domvanalimab or domvanalimab in Combination with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Measured: From First Dose Date to 100 Days After Last Dose
Secondary outcomes (12)
AB154 Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of domvanalimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of zimberelimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Time of Peak Concentration (Tmax)
Time of Peak Concentration (Tmax) of domvanalimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Time of Peak Concentration (Tmax)
Time of Peak Concentration (Tmax) of zimberelimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve (AUC) of domvanalimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve (AUC) of zimberelimab
Measured: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Immunogenicity Indicators: Anti-Drug Antibodies (ADA)
Number of Participants who Develop Antidrug Antibodies to AB154 and/or AB122
Measured: Day 1, Day 15, Day 29, Day 43, Day 57, Day 85 and 30 Days After Last Dose, up to 52 weeks
Overall Response Rate
Number of Participants with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.1
Measured: First Dose Date to Progression or Last Tumor Assessment, up to 1 year
Duration of Response
Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per RECIST v1.1
Measured: Start Date of Response to First Progression/Death, up to 1 year
Disease Control Rate
Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
Measured: First Dose Date to First Progression/Death, up to 1 year
Progression Free Survival
Number of Participants Without Disease Progression per RECIST v1.1
Measured: First Dose Date to First Progression/Death, up to 1 year
Overall Survival
Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death
Measured: First Dose Date to Date of Death, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start12 Sep 2018
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Unspecified, AdultStudies of the same condition, open and under way.
- 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
- Model description
- Dose Escalation Design
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628677
- Sponsor's protocol ID
- AB154CSP0001
- Status last verified
- May 2024
- First submitted
- 26 Jul 2018
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents \[e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)\] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03628677
- Acronym / sponsor ID
- AB154CSP0001
- Conditions
- Solid Tumor, Unspecified, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 14 Aug 2018 (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 Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose Escalation Design
| Arm | Type | Receives |
|---|---|---|
| Domvanalimab Monotherapy | Experimental | Drug: DomvanalimabVarying Doses of domvanalimab Monotherapy |
| Domvanalimab + zimberelimab Q2W Combination Therapy | Experimental | Drug: Domvanalimab, Drug: ZimberelimabVarying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab + zimberelimab Q3W Combination Therapy | Experimental | Drug: Domvanalimab, Drug: ZimberelimabVarying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab + zimberelimab Q4W Combination Therapy | Experimental | Drug: Domvanalimab, Drug: ZimberelimabVarying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab and Zimberelimab Q6W combination therapy | Experimental | Drug: Domvanalimab, Drug: ZimberelimabVarying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W | Experimental | Drug: Domvanalimab, Drug: ZimberelimabVarying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving signed informed consent
- Male or female participants ≥ 18 years of age at the time of screening
- Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1; negative serum or urine pregnancy test on the first day of each subsequent treatment period
- Participants with any pathologically confirmed solid tumor type for which no standard of care therapy exists
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation
Key exclusion criteria (9 listed)
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of domvanalimab as monotherapy and in combination with zimberelimab.
- Participants who require a Legally Authorized Representative (LAR) to provide informed consent on their behalf.
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 |
|---|---|---|
| DomvanalimabAlso: AB154Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT | Drug | Domvanalimab + zimberelimab Q2W Combination Therapy, Domvanalimab + zimberelimab Q3W Combination Therapy, Domvanalimab + zimberelimab Q4W Combination Therapy, Domvanalimab Monotherapy, Domvanalimab and Zimberelimab Q6W combination therapy, Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W |
| ZimberelimabAlso: AB122Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1 | Drug | Domvanalimab + zimberelimab Q2W Combination Therapy, Domvanalimab + zimberelimab Q3W Combination Therapy, Domvanalimab + zimberelimab Q4W Combination Therapy, Domvanalimab and Zimberelimab Q6W combination therapy, Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame: From First Dose Date to 100 Days After Last Dose
Number of Participants Treated with domvanalimab or domvanalimab in Combination with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
12 secondary outcomes
AB154 Peak Plasma Concentration (Cmax)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Peak Plasma Concentration (Cmax)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Time of Peak Concentration (Tmax)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Time of Peak Concentration (Tmax)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Immunogenicity Indicators: Anti-Drug Antibodies (ADA)
Time frame: Day 1, Day 15, Day 29, Day 43, Day 57, Day 85 and 30 Days After Last Dose, up to 52 weeks
Overall Response Rate
Time frame: First Dose Date to Progression or Last Tumor Assessment, up to 1 year
Duration of Response
Time frame: Start Date of Response to First Progression/Death, up to 1 year
Disease Control Rate
Time frame: First Dose Date to First Progression/Death, up to 1 year
Progression Free Survival
Time frame: First Dose Date to First Progression/Death, up to 1 year
Overall Survival
Time frame: First Dose Date to Date of Death, up to 1 year
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 4 Feb 2025.
- AB154CSP0001 - Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents [e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
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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.
Medical Director study director
Arcus Biosciences, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Domvanalimab and Zimberelimab in people with Solid Tumor, Unspecified, Adult, run by Arcus Biosciences, Inc. at 10 sites in 2 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 9 inclusion and 9 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. 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?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 (time frame: From First Dose Date to 100 Days After Last Dose). 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 4 Feb 2025.