Solid TumorPhase 1NCT06487858
A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors
A Phase 1 study testing BGB-R046 and Tislelizumab in people with Solid Tumor, run by BeOne Medicines at 8 sites in China.
Trial summary
This is a first-in-human (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BGB-R046 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesChina
- Study dates
- 16 Jul 2024to 9 Apr 2026
- 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 able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
- Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement
- ≥ 1 measurable lesion per RECIST v1.1
- Able to provide an archived tumor tissue sample
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
- Life expectancy >12 weeks as determined by the investigator
Who cannot join
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s)
- History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
- Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4, or other experimental drugs)
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- Uncontrolled diabetes > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drug(s).
- Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s)
- Immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jinan Central Hospital
Jinan, Shandong, 250013
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Multicenter Open-Label Phase 1a/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
This is a first-in-human (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors.
Read the detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
- Conditions
- Solid Tumor
- Being tested
- BGB-R046, Tislelizumab
- Keywords
- BGB-R046, First-in-human, Advanced solid tumor, Anti-Programmed Death-1 (Anti-PD1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-R046Drug
Intravenous administration
TislelizumabDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Part A: Dose Escalation Monotherapy | Experimental | Sequential cohorts of increasing dose levels of BGB R046 will be evaluated as monotherapy. Receives: Drug: BGB-R046 |
| Phase 1a: Part B: Dose Escalation Combination Therapy | Experimental | Sequential cohorts of increasing dose levels of BGB R046 will be evaluated in combination with tislelizumab. Receives: Drug: BGB-R046; Drug: Tislelizumab |
| Phase 1b: Dose Expansion and Dose Optimization | Experimental | The recommended dose(s) for expansion (RDFE) for BGB-R046 in combination with tislelizumab from Phase 1a will be evaluated in selected indications. Receives: Drug: BGB-R046; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participant with Adverse Events, Serious Adverse Events, Adverse Events of Clinical Interest and Dose-limiting Toxicities
Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome [CRS] and immune effector cell associated neurotoxicity syndrome [ICANS])
Measured: Up to approximately 2 years
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-R046
MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
Measured: Up to approximately 2 years
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-R046
The potential RDFE[s] of BGB-R046 administered as monotherapy and in combination with tislelizumab will be determined based on the totality of the data and will also take in consideration the long term tolerability, pharmacokinetics, preliminary antitumor activity and any other relevant data available
Measured: Up to approximately 2 years
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to approximately 2 years
Secondary outcomes (15)
Phase 1a: ORR
ORR is defined as the percentage of participants with confirmed CR or PR as determined by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Phase 1a: Time to Response (TTR)
TTR is defined as the time from the date of the first dose of study drug(s) to the date of the first determination of overall response by the investigator using RECIST v1.1
Measured: Up to approximately 2 years
Phase 1a: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks
Measured: Up to approximately 2 years
Phase 1a and Phase 1b: Duration of Response (DOR)
DOR is defined as the time from the first objective response until the first documentation of disease progression after treatment initiation or death, whichever comes first, as determined by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Phase 1a and Phase 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Phase 1b: Progression-free survival (PFS)
PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Measured: Up to approximately 2 years
Phase 1b: Number of Participants with Adverse Events (AEs)
Number of participants with AEs, including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings, physical examination, or electrocardiogram results), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by NCI-CTCAE V5.0 or ASTCT as appropriate
Measured: Up to approximately 2 years
Phase 1a: Plasma concentrations of BGB-R046 analytes
Measured: Predose and at select time points in Cycles 1, 2 and 5; predose at select Cycles between Cycles 3 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1b: Plasma concentrations of BGB-R046 analytes
Measured: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1b: Plasma concentrations of tislelizumab
Measured: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 17 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-R046
Measured: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Minimum Observed Plasma Concentration (Ctrough) Of BGB-R046
Measured: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BGB-R046
Measured: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Terminal Half-Life (t1/2) of BGB-R046
Measured: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-R046 and tislelizumab
Measured: Periodic sampling up to Cycle 25 (each cycle is 21 days) and at the first safety follow up visit up to approximately 2 years (conducted 30 days after the last dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start16 Jul 2024
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Why it stopped: This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487858
- Sponsor's protocol ID
- BGB-R046-101
- Status last verified
- May 2026
- First submitted
- 20 Jun 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Phase 1a/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06487858
- Acronym / sponsor ID
- BGB-R046-101
- Conditions
- Solid Tumor
- Keywords
- BGB-R046, First-in-human, Advanced solid tumor, Anti-Programmed Death-1 (Anti-PD1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 5 Jul 2024 (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 (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Part A: Dose Escalation Monotherapy | Experimental | Drug: BGB-R046Sequential cohorts of increasing dose levels of BGB R046 will be evaluated as monotherapy. |
| Phase 1a: Part B: Dose Escalation Combination Therapy | Experimental | Drug: BGB-R046, Drug: TislelizumabSequential cohorts of increasing dose levels of BGB R046 will be evaluated in combination with tislelizumab. |
| Phase 1b: Dose Expansion and Dose Optimization | Experimental | Drug: BGB-R046, Drug: TislelizumabThe recommended dose(s) for expansion (RDFE) for BGB-R046 in combination with tislelizumab from Phase 1a will be evaluated in selected indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
- Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement
- ≥ 1 measurable lesion per RECIST v1.1
- Able to provide an archived tumor tissue sample
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Key exclusion criteria (10 listed)
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s)
- History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
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 |
|---|---|---|
| BGB-R046Intravenous administration | Drug | Phase 1a: Part A: Dose Escalation Monotherapy, Phase 1a: Part B: Dose Escalation Combination Therapy, Phase 1b: Dose Expansion and Dose Optimization |
| TislelizumabIntravenous administration | Drug | Phase 1a: Part B: Dose Escalation Combination Therapy, Phase 1b: Dose Expansion and Dose Optimization |
Primary outcome
Phase 1a: Number of Participant with Adverse Events, Serious Adverse Events, Adverse Events of Clinical Interest and Dose-limiting Toxicities
Time frame: Up to approximately 2 years
Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome [CRS] and immune effector cell associated neurotoxicity syndrome [ICANS])
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-R046
Time frame: Up to approximately 2 years
MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BGB-R046
Time frame: Up to approximately 2 years
The potential RDFE[s] of BGB-R046 administered as monotherapy and in combination with tislelizumab will be determined based on the totality of the data and will also take in consideration the long term tolerability, pharmacokinetics, preliminary antitumor activity and any other relevant data available
Phase 1b: Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
15 secondary outcomes
Phase 1a: ORR
Time frame: Up to approximately 2 years
Phase 1a: Time to Response (TTR)
Time frame: Up to approximately 2 years
Phase 1a: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 2 years
Phase 1a and Phase 1b: Duration of Response (DOR)
Time frame: Up to approximately 2 years
Phase 1a and Phase 1b: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Phase 1b: Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Phase 1b: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Phase 1a: Plasma concentrations of BGB-R046 analytes
Time frame: Predose and at select time points in Cycles 1, 2 and 5; predose at select Cycles between Cycles 3 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1b: Plasma concentrations of BGB-R046 analytes
Time frame: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 25 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1b: Plasma concentrations of tislelizumab
Time frame: Predose and after end of infusion in Cycles 1 and 5; predose at select Cycles between Cycles 1 and 17 (each cycle is 21 days); and at the first safety follow-up visit (conducted 30 days after the last dose of study drug)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-R046
Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Minimum Observed Plasma Concentration (Ctrough) Of BGB-R046
Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BGB-R046
Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Terminal Half-Life (t1/2) of BGB-R046
Time frame: Cycle 1 and Cycle 5 (each cycle is 21 days)
Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-R046 and tislelizumab
Time frame: Periodic sampling up to Cycle 25 (each cycle is 21 days) and at the first safety follow up visit up to approximately 2 years (conducted 30 days after the last dose of study drug)
Results and safety
The study was stopped early (reason given: This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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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.
Study Director study director
BeOne Medicines
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-R046 and Tislelizumab in people with Solid Tumor, run by BeOne Medicines at 8 sites in China.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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 was stopped early (reason given: This decision is due to a company business decision with a strategy change on the BGB-R046 development in Advanced or Metastatic Solid Tumors.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participant with Adverse Events, Serious Adverse Events, Adverse Events of Clinical Interest and Dose-limiting Toxicities (time frame: Up to approximately 2 years). 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 11 May 2026.