Clinical trial NCT03379259: Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2017-12-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. This study tested the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in participants with advanced solid tumors.


Eligibility criteria: Key Inclusion Criteria:

1. 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
2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
3. Has adequate organ function

Key Exclusion Criteria:

1. Active brain or leptomeningeal metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
3. 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)
4. Concurrent participation in another therapeutic clinical trial.
5. Received prior therapies targeting PD-1 or PD-L1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to 33.5 months
measure: Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
timeFrame: Up to 33.5 months
measure: Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
timeFrame: Up to 33.5 months
measure: Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
timeFrame: Up to 33.5 months
measure: Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
timeFrame: Up to 28 months
measure: Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
timeFrame: Up to 33.5 months
Secondary outcomes:
measure: Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
timeFrame: Up to 33.5 months
measure: Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
timeFrame: Up to 33.5 months
measure: Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
timeFrame: Up to 33.5 months
measure: Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
timeFrame: Up to 33.5 months
measure: Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
timeFrame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
measure: Phase 1: Time to Cmax (Tmax) of BGB-A333
timeFrame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
measure: Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
timeFrame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
measure: Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
timeFrame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
measure: Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
timeFrame: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
measure: Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
timeFrame: Up to 33.5 months
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Barcelona
country: Spain
facility: Institut Catala Doncologia
city: Madrid
country: Spain
facility: Start Madrid Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References: