Advanced Solid TumorsPhase 1/2NCT03379259

Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors

A Phase 1/2 study testing BGB-A333 and BGB-A317 in people with Advanced Solid Tumors, run by BeiGene at 8 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death 1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1 (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. 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-A333 and BGB-A317
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 8 sitesin 3 countries
Study dates: 27 Nov 2017to 8 Sep 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard therapy or for which treatment is not available, not tolerated or refused
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Has adequate organ function

Who cannot join

Active brain or leptomeningeal metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma)
Concurrent participation in another therapeutic clinical trial.
Received prior therapies targeting PD-1 or PD-L1.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Australia4 sites

Monash Health
Clayton, Victoria, 3168
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Nucleus Network
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009

Other trials in Australia

Spain3 sites

Institut Catala Doncologia
Barcelona, 08908
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040
Centro Integral Oncologico Clara Campal
Madrid, 28050

Other trials in Spain

New Zealand1 site

Auckland City Hospital
Auckland, 1023

Other trials in New Zealand

About this study

Official title: Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Conditions: Advanced Solid Tumors
Being tested: BGB-A333, BGB-A317

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BGB-A333Drug
Anti-PD-L1 antibody
BGB-A317Drug
Also called Tislelizumab
Anti-PD-1 antibodies

Study groups in NCT03379259
Study group	Role	What they receive
Phase 1A: BGB-A333 monotherapy dose escalation	Experimental	Not described Receives: Drug: BGB-A333
Phase 2A: BGB-A333 monotherapy dose expansion	Experimental	Not described Receives: Drug: BGB-A333
Phase 1B: BGB-A333 and BGB-A317 dose confirmation	Experimental	Not described Receives: Drug: BGB-A333; Drug: BGB-A317
Phase 2B: BGB-A333 and BGB-A317 dose expansion	Experimental	Not described Receives: Drug: BGB-A333; Drug: BGB-A317

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Measured: Up to 33.5 months
Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Measured: Up to 33.5 months
Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Measured: Up to 33.5 months
Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
Lab abnormality was based on ANRIND: if the measurement value > upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Measured: Up to 33.5 months
Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg.
Measured: Up to 28 months
Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1
Measured: Up to 33.5 months

Secondary outcomes (10)

Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
ORR is defined as the percentage of participants who had confirmed CR or PR assessed by investigator using RECIST version 1.1.
Measured: Up to 33.5 months
Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
DOR was defined as the time from the first determination of an objective response per RECIST version 1.1, until the first documentation of progression or death, whichever occurs first. DOR was not evaluable in Phase 1A and Phase 1B.
Measured: Up to 33.5 months
Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
DCR is defined as the percentage of participants with best overall response of CR, PR and Stable Disease.
Measured: Up to 33.5 months
Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator using RECIST v1.1 or death, whichever occurs first
Measured: Up to 33.5 months
Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B pharmacokinetic (PK) parameters were not estimated due to limited sampling.
Measured: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Time to Cmax (Tmax) of BGB-A333
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Measured: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Measured: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. Actual observed time values for PK sampling, have an allowable time deviation (+/- 3 days) from the planned nominal time as pre-specified in the Visit Window section of the study protocol.
Measured: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Measured: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
Treatment-emergent anti drug antibodies (ADA) was the sum of both treatment-induced ADA and treatment-boosted ADA, synonymous with "ADA Incidence."
Measured: Up to 33.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 20178 Sep 2020

First posted20 Dec 2017
Study start27 Nov 2017
Primary completion8 Sep 2020
Study completion8 Sep 2020

Why it stopped: Study Was Terminated Early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03379259
Sponsor's protocol ID: BGB-900-101
Other IDs: 2018-000265-37, 2018
Status last verified: Oct 2024
First submitted: 11 Dec 2017
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Desai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Martin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer. 2023 Apr;128(8):1418-1428. doi: 10.1038/s41416-022-02128-3. Epub 2023 Feb 16.
PubMed 36797356

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03379259
Acronym / sponsor ID: BGB-900-101
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study Was Terminated Early
Enrolment: 39 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 27 Nov 2017 (actual)
Primary completion: 8 Sep 2020 (actual)
Study completion: 8 Sep 2020 (actual)
First posted: 20 Dec 2017 (actual)
Results: Posted 9 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1A: BGB-A333 monotherapy dose escalation	Experimental	Drug: BGB-A333
Phase 2A: BGB-A333 monotherapy dose expansion	Experimental	Drug: BGB-A333
Phase 1B: BGB-A333 and BGB-A317 dose confirmation	Experimental	Drug: BGB-A333, Drug: BGB-A317
Phase 2B: BGB-A333 and BGB-A317 dose expansion	Experimental	Drug: BGB-A333, Drug: BGB-A317

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard therapy or for which treatment is not available, not tolerated or refused
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Has adequate organ function

Key exclusion criteria (6 listed)

Active brain or leptomeningeal metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma)
Concurrent participation in another therapeutic clinical trial.
Received prior therapies targeting PD-1 or PD-L1.

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-A333Anti-PD-L1 antibody	Drug	Phase 1A: BGB-A333 monotherapy dose escalation, Phase 1B: BGB-A333 and BGB-A317 dose confirmation, Phase 2A: BGB-A333 monotherapy dose expansion, Phase 2B: BGB-A333 and BGB-A317 dose expansion
BGB-A317Also: TislelizumabAnti-PD-1 antibodies	Drug	Phase 1B: BGB-A333 and BGB-A317 dose confirmation, Phase 2B: BGB-A333 and BGB-A317 dose expansion

Primary outcome

Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 33.5 months
Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
Time frame: Up to 33.5 months
Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
Time frame: Up to 33.5 months
Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
Time frame: Up to 33.5 months
Lab abnormality was based on ANRIND: if the measurement value > upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
Time frame: Up to 28 months
RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg.
Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
Time frame: Up to 33.5 months
The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1

10 secondary outcomes

Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
Time frame: Up to 33.5 months
Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
Time frame: Up to 33.5 months
Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
Time frame: Up to 33.5 months
Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
Time frame: Up to 33.5 months
Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
Time frame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Time to Cmax (Tmax) of BGB-A333
Time frame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
Time frame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
Time frame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
Time frame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
Time frame: Up to 33.5 months

Results and safety

Results posted to the registry on 9 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1A: BGB-A333 450 mg	3	2
Phase 1A: BGB-A333 900mg	3	2
Phase 1A: BGB-A333 1350 mg	6	3
Phase 1A: BGB-A333 1800 mg	3	0
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg	12	3
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg	12	5

Primary outcome: Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events

Time frame: Up to 33.5 months. Count of participants. Unit: Participants

Measure	Phase 1A: BGB-A333 450 mg n = 3	Phase 1A: BGB-A333 900 mg n = 3	Phase 1A: BGB-A333 1350 mg n = 6	Phase 1A: BGB-A333 1800 mg n = 3	Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg n = 12	Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg n = 12
Any Treatment Emergent Adverse Event (TEAE)	1	2	6	3	12	12
Serious TEAE	0	1	3	1	5	3

Population analysed: Safety Analysis Set included all participants who received at least 1 dose of study drug.

Primary outcome: Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings

Time frame: Up to 33.5 months. Number. Unit: participants

Measure	Phase 1A: BGB-A333 450 mg n = 3	Phase 1A: BGB-A333 900 mg n = 3	Phase 1A: BGB-A333 1350 mg n = 6	Phase 1A: BGB-A333 1800 mg n = 3	Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg n = 12	Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg n = 12
Value	0	0	0	0	0	0

Population analysed: Safety Analysis Set included all participants who received at least 1 dose of study drug.

Primary outcome: Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)

Time frame: Up to 33.5 months. Number. Unit: participants

Measure	Phase 1A: BGB-A333 450 mg n = 3	Phase 1A: BGB-A333 900 mg n = 3	Phase 1A: BGB-A333 1350 mg n = 6	Phase 1A: BGB-A333 1800 mg n = 3	Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg n = 12	Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg n = 12
Value	0	1	5	2	1	9

Population analysed: Safety Analysis Set included all participants who received at least 1 dose of study drug.

Primary outcome: Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results

Time frame: Up to 33.5 months. Number. Unit: participants

Measure	Phase 1A: BGB-A333 450 mg n = 3	Phase 1A: BGB-A333 900 mg n = 3	Phase 1A: BGB-A333 1350 mg n = 6	Phase 1A: BGB-A333 1800 mg n = 3	Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg n = 12	Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg n = 12
Value	3	3	6	3	12	12

Population analysed: Safety Analysis Set included all participants who received at least 1 dose of study drug.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of consent until study termination (Approximately 33.5 months). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1A: BGB-A333 450 mg	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Phase 1A: BGB-A333 900 mg	1 of 3 (33.3%)	2 of 3 (66.7%)	1 of 3
Phase 1A: BGB-333 1350 mg	3 of 6 (50%)	6 of 6 (100%)	2 of 6
Phase 1A: BGB-333 1800 mg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg	5 of 12 (41.7%)	12 of 12 (100%)	4 of 12
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg	3 of 12 (25%)	12 of 12 (100%)	2 of 12

Limitations and caveats (from the sponsor): Phase 2A of the study was not initiated nor conducted since BGB-A333 as a monotherapy treatment beyond the completion of dose escalation in Phase 1A was not pursued.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36797356Desai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Martin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer. 2023 Apr;128(8):1418-1428. doi: 10.1038/s41416-022-02128-3. Epub 2023 Feb 16.
Individual participant dataSharing planned: Yes

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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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 principal investigator

BeiGene

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGB-A333 and BGB-A317 in people with Advanced Solid Tumors, run by BeiGene at 8 sites in 3 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 3 inclusion and 6 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 26 Oct 2024. 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 Australia, Spain, New Zealand. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events (time frame: Up to 33.5 months). The study lists 6 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 NCT03379259, 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 26 Oct 2024.