Advanced Solid TumorsPhase 1NCT05904496
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BGB-30813 and Tislelizumab in people with Advanced Solid Tumors, run by BeiGene at 11 sites in 4 countries.
Trial summary
This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-30813 as monotherapy or in combination with tislelizumab in participants with advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BGB-30813 and Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 19 Jul 2023to 20 Aug 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
- Phase 1a (Dose Escalation):
- Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting diacylglycerol kinase (DGK)
- Eligible tumor types are immune sensitive solid tumors such as non-small cell lung cancer (NSCLC), head neck squamous cell cancer (HNSCC), small cell lung cancer, hepatocellular carcinoma, esophageal cancer, gastric or gastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breast cancer, urothelial carcinoma, renal cell carcinoma, cervical cancer, endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutation burden (TMB)-high, or mismatch repair deficient solid tumors
- Prior checkpoint inhibitor (CPI) therapy is allowed
- Phase 1b (Dose Expansion):
- Participants with selected advanced or metastatic solid tumors including NSCLC, HNSCC, and additional potential tumor types to be defined based on emerging data
Show all 10Show fewer
- ≥ 1 measurable lesion per RECIST v1.1
- Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score ≤ 1
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
- Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 grams per liter (g/L), Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (< 3 x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Who cannot join
- Previous therapy targeting DGK
- Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS) metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- Systemic anticancer therapy, including chemotherapy ≤ 21 days or 5 half-lives (whichever is shorter) before the first dose of study drugs
- ≥ Grade 3 immune-mediated adverse events on prior immuno-oncology agent (anti-PD-1 or anti-CTLA4 antibodies or other experimental drugs)
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States3 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
Md Anderson Cancer Center
Houston, Texas, 77030-3907
Next Oncology
San Antonio, Texas, 78229-6028
Australia3 sites
Monash Health
Clayton, Victoria, 3168
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Linear Clinical Research
Nedlands, Western Australia, 6009
China3 sites
Jinan Central Hospital
Jinan, Shandong, 250013
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shandong Cancer Hospital
Jinan, Shandong, 250117
Spain2 sites
Hospital Universitario Vall Dhebron
Barcelona, 08035
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040
About this study
Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-30813 as monotherapy or in combination with tislelizumab in participants with advanced or metastatic solid tumors. The study will be conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
Read the detailed description
This study will test whether taking BGB-30813 alone or with tislelizumab can help treat patients with cancer that has spread throughout the body or is locally advanced. The two main goals of the study are to ensure that the treatments are safe by monitoring side effects and to determine the number of participants who respond well to treatment either partially or completely. The combination of BGB-30813 with other drugs that target immune checkpoints may work together to stop or prevent cancer activity.
Approximately 200 participants will participate. In the first part of the study, participants will be given different doses of BGB-30813 either alone or with tislelizumab to find the dose that is best tolerated. BGB-30813 will be given orally and tislelizumab will be given through a vein. In the second part of the study, the selected dose of BGB-30813, either alone or with tislelizumab, will be given to a larger number of participants from different parts of the world to see if the treatments can improve the signs and symptoms of their cancer. Treatments will continue until participants are no longer considered to be receiving benefits, have unacceptable side effects, or withdraw consent.
- Conditions
- Advanced Solid Tumors
- Being tested
- BGB-30813, Tislelizumab
- Keywords
- DGKζ Inhibitor, BGB-30813, Anti-PD-1 Monoclonal Antibody, Tislelizumab, Advanced or Metastatic Solid Tumors, Diacylglycerol kinase, BGB-A317, NSCLC, Immunotherapy, HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-30813Drug
Specified dose administered on specified days
TislelizumabDrug
Also called BGB-A317
Specified dose administered on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy | Experimental | Not described Receives: Drug: BGB-30813 |
| Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab | Experimental | Not described Receives: Drug: BGB-30813; Drug: Tislelizumab |
| Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab | Experimental | Not described Receives: Drug: BGB-30813; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
Number of participants experiencing AEs and SAEs, including physical examination findings, electrocardiograms (ECGs), and lab assessments as needed; and AEs meeting protocol-defined DLT criteria.
Measured: From the first dose of study drug(s) to 30 days after the last dose; approximately 6 months
Phase 1a: Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD)
The MTD or MAD is defined as the highest dose at which 30% of participants experience a DLT or the highest dose administered, respectively.
Measured: Up to approximately 6 months
Phase 1a and 1b: Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
The RDFE(s) of BGB-30813 alone or in combination with tislelizumab, determined based upon the MTD or MAD and other relevant data.
Measured: Up to approximately 6 months
Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to approximately 12 months
Secondary outcomes (11)
Phase 1a: Dose Escalation: ORR as Determined by the Investigator
ORR is defined as the percentage of participants who had confirmed CR or PR as determined from tumor assessments by the investigator per RECIST version 1.1
Measured: Up to approximately 12 months
Phase 1a: Dose Escalation: Maximum Observed Plasma Concentration (Cmax) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Measured: Up to approximately 6 months
Phase 1a: Dose Escalation: Observed Plasma Trough Concentration (Ctrough) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Measured: Up to approximately 6 months
Phase 1a: Dose Escalation: Area under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Measured: Up to approximately 6 months
Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Measured: Up to approximately 6 months
Phase 1b: Dose Expansion: Number of Participants Experiencing AEs and SAEs
Number of participants experiencing AEs and SAEs, including physical examination findings, ECGs, and lab assessments as needed.
Measured: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months
Phase 1b: Dose Expansion: Duration of Response (DOR)
DOR is defined as the time from the first determination of an overall response assessed by the investigator using RECIST v1.1, until the first documentation of disease progression or death, whichever comes first.
Measured: Up to approximately 12 months
Phase 1b: Dose Expansion: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response (BOR) of complete Response (CR), Partial Response (PR), or stable disease assessed by the investigator using RECIST v1.1.
Measured: Up to approximately 12 months
Phase 1b: Dose Expansion: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drugs to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Measured: Up to approximately 12 months
Phase 1b: Dose Expansion: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with BOR of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by the investigator using RECIST v1.1.
Measured: Up to approximately 12 months
Phase 1b: Dose Expansion: Plasma concentrations of BGB-30813, and its metabolite, BGB-33481
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start19 Jul 2023
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Why it stopped: The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904496
- Sponsor's protocol ID
- BGB-A317-30813-101
- Other IDs
- U1111-1290-6118, 2023-503996-38, CTR20233404, 2023
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene 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. BeiGene 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 BeiGene 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05904496
- Acronym / sponsor ID
- BGB-A317-30813-101
- Conditions
- Advanced Solid Tumors
- Keywords
- DGKζ Inhibitor, BGB-30813, Anti-PD-1 Monoclonal Antibody, Tislelizumab, Advanced or Metastatic Solid Tumors, Diacylglycerol kinase, BGB-A317, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 15 Jun 2023 (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) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-30813 as monotherapy or in combination with tislelizumab in participants with advanced or metastatic solid tumors. The study will be conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
Detailed description
This study will test whether taking BGB-30813 alone or with tislelizumab can help treat patients with cancer that has spread throughout the body or is locally advanced. The two main goals of the study are to ensure that the treatments are safe by monitoring side effects and to determine the number of participants who respond well to treatment either partially or completely. The combination of BGB-30813 with other drugs that target immune checkpoints may work together to stop or prevent cancer activity.
Approximately 200 participants will participate. In the first part of the study, participants will be given different doses of BGB-30813 either alone or with tislelizumab to find the dose that is best tolerated. BGB-30813 will be given orally and tislelizumab will be given through a vein. In the second part of the study, the selected dose of BGB-30813, either alone or with tislelizumab, will be given to a larger number of participants from different parts of the world to see if the treatments can improve the signs and symptoms of their cancer. Treatments will continue until participants are no longer considered to be receiving benefits, have unacceptable side effects, or withdraw consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy | Experimental | Drug: BGB-30813 |
| Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab | Experimental | Drug: BGB-30813, Drug: Tislelizumab |
| Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab | Experimental | Drug: BGB-30813, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Phase 1a (Dose Escalation):
- Phase 1b (Dose Expansion):
- ≥ 1 measurable lesion per RECIST v1.1
- Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score ≤ 1
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
Key exclusion criteria (7 listed)
- Previous therapy targeting DGK
- Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS) metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- Systemic anticancer therapy, including chemotherapy ≤ 21 days or 5 half-lives (whichever is shorter) before the first dose of study drugs
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-30813Specified dose administered on specified days | Drug | Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy, Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab, Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab |
| TislelizumabAlso: BGB-A317Specified dose administered on specified days | Drug | Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab, Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab |
Primary outcome
Phase 1a: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose of study drug(s) to 30 days after the last dose; approximately 6 months
Number of participants experiencing AEs and SAEs, including physical examination findings, electrocardiograms (ECGs), and lab assessments as needed; and AEs meeting protocol-defined DLT criteria.
Phase 1a: Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD)
Time frame: Up to approximately 6 months
The MTD or MAD is defined as the highest dose at which 30% of participants experience a DLT or the highest dose administered, respectively.
Phase 1a and 1b: Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
Time frame: Up to approximately 6 months
The RDFE(s) of BGB-30813 alone or in combination with tislelizumab, determined based upon the MTD or MAD and other relevant data.
Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
Time frame: Up to approximately 12 months
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
11 secondary outcomes
Phase 1a: Dose Escalation: ORR as Determined by the Investigator
Time frame: Up to approximately 12 months
Phase 1a: Dose Escalation: Maximum Observed Plasma Concentration (Cmax) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Time frame: Up to approximately 6 months
Phase 1a: Dose Escalation: Observed Plasma Trough Concentration (Ctrough) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Time frame: Up to approximately 6 months
Phase 1a: Dose Escalation: Area under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Time frame: Up to approximately 6 months
Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Time frame: Up to approximately 6 months
Phase 1b: Dose Expansion: Number of Participants Experiencing AEs and SAEs
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months
Phase 1b: Dose Expansion: Duration of Response (DOR)
Time frame: Up to approximately 12 months
Phase 1b: Dose Expansion: Disease Control Rate (DCR)
Time frame: Up to approximately 12 months
Phase 1b: Dose Expansion: Progression Free Survival (PFS)
Time frame: Up to approximately 12 months
Phase 1b: Dose Expansion: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 12 months
Phase 1b: Dose Expansion: Plasma concentrations of BGB-30813, and its metabolite, BGB-33481
Time frame: Up to approximately 6 months
Results and safety
The study was stopped early (reason given: The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. BeiGene 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. BeiGene 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 BeiGene 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
BeiGene
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-30813 and Tislelizumab in people with Advanced Solid Tumors, run by BeiGene at 11 sites in 4 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 7 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, China, Spain. 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: The Sponsor has made the decision to discontinue the clinical development of BGB-30813 and close the study based on imbalanced benefit/risk profile in the BGB-A317-30813-101 study.). 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: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs) (time frame: From the first dose of study drug(s) to 30 days after the last dose; approximately 6 months). 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 16 Sep 2025.