Last reviewed · How we verify

NCT02660034

The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 6 December 2021
What this trial tests

Phase 1 trial testing Tislelizumab in Solid Tumors in 229 participants. Completed in 9 September 2020.

Timeline
2 February 2016
Primary endpoint
9 September 2020
9 September 2020

Quick facts

Lead sponsorBeiGene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment229
Start date2 February 2016
Primary completion9 September 2020
Estimated completion9 September 2020
Sites29 locations across France, New Zealand, United Kingdom, Australia, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Number Of Participants Experiencing Adverse Events (AEs) Primary · From Day 1 up to 4 years and 7 months

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardl

GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 112
Part A: Dose Escalation Phase - Cohort 212
Part A: Dose Escalation Phase - Cohort 36
Part A: Dose Escalation Phase - Cohort 413
Part A: Dose Escalation Phase - Cohort 56
Part A: Number Of Participants Experiencing Dose-limiting Toxicity (DLT) Primary · 21 days following the first dose of tislelizumab and pamiparib in Cycle 1

DLT was defined as an AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and occurs during the first 21 days following the first dose of tislelizumab and pamiparib in Cycle 1 and meets protocol-specified criteria. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 10
Part A: Dose Escalation Phase - Cohort 20
Part A: Dose Escalation Phase - Cohort 30
Part A: Dose Escalation Phase - Cohort 42
Part A: Dose Escalation Phase - Cohort 52
Part B: Objective Response Rate (ORR) Primary · Starting from Day 1 until disease progression (up to 4 years and 7 months)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) and partial response (PR).

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a7
Part B: Dose Expansion Phase - Arm 1b3
Part B: Dose Expansion Phase - Arm 29
Part B: Dose Expansion Phase - Arm 34
Part B: Dose Expansion Phase - Arm 42
Part B: Dose Expansion Phase - Arm 52
Part B: Dose Expansion Phase - Arm 66
Part B: Dose Expansion Phase - Arm 70
Part B: Dose Expansion Phase - Arm 83
Part B: Progression-free Survival (PFS) Primary · Starting from Day 1 until disease progression (up to 4 years and 7 months)

PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a8.25.2 – 11.8
Part B: Dose Expansion Phase - Arm 1b3.51.9 – 7.6
Part B: Dose Expansion Phase - Arm 28.43.9 – 19.0
Part B: Dose Expansion Phase - Arm 310.44.3 – 16.2
Part B: Dose Expansion Phase - Arm 42.01.7 – 2.3
Part B: Dose Expansion Phase - Arm 52.11.9 – 4.1
Part B: Dose Expansion Phase - Arm 63.51.9 – 7.5
Part B: Dose Expansion Phase - Arm 71.91.1 – 2.1
Part B: Dose Expansion Phase - Arm 82.21.2 – 24.4
Part B: Duration Of Response (DOR) Primary · Starting from Day 1 until disease progression (up to 4 years and 7 months)

DOR, defined as the time from the first determination of an objective response, was assessed by investigator per Response Evaluation Criteria in Solid Tumors v1.1 until the first documentation of progression or death, whichever occurred first. Results are reported only for arms with responders.

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a11.26.2 – NA
Part B: Dose Expansion Phase - Arm 1b6.23.8 – NA
Part B: Dose Expansion Phase - Arm 217.13.0 – NA
Part B: Dose Expansion Phase - Arm 3NA4.1 – NA
Part B: Dose Expansion Phase - Arm 46.24.3 – 8.1
Part B: Dose Expansion Phase - Arm 5NANA – NA
Part B: Dose Expansion Phase - Arm 6NA5.7 – NA
Part B: Dose Expansion Phase - Arm 8NA22.4 – NA
Part B: Disease Control Rate (DCR) Primary · Starting from Day 1 until disease progression (up to 4 years and 7 months)

DCR was defined as the percentage of participants with a best overall response of CR, PR, and stable disease (SD).

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a21
Part B: Dose Expansion Phase - Arm 1b11
Part B: Dose Expansion Phase - Arm 214
Part B: Dose Expansion Phase - Arm 315
Part B: Dose Expansion Phase - Arm 47
Part B: Dose Expansion Phase - Arm 57
Part B: Dose Expansion Phase - Arm 612
Part B: Dose Expansion Phase - Arm 72
Part B: Dose Expansion Phase - Arm 84
Part B: Clinical Benefit Rate (CBR) Primary · Starting from Day 1 until disease progression (up to 4 years and 7 months)

CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a15
Part B: Dose Expansion Phase - Arm 1b7
Part B: Dose Expansion Phase - Arm 211
Part B: Dose Expansion Phase - Arm 310
Part B: Dose Expansion Phase - Arm 44
Part B: Dose Expansion Phase - Arm 54
Part B: Dose Expansion Phase - Arm 68
Part B: Dose Expansion Phase - Arm 71
Part B: Dose Expansion Phase - Arm 83
Part B: Overall Survival (OS) Primary · From Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

OS was defined as the time from the date of first dose of study drug to death due to any cause.

GroupValue95% CI
Part B: Dose Expansion Phase - Arm 1a20.913.5 – NA
Part B: Dose Expansion Phase - Arm 1b18.76.1 – 27.0
Part B: Dose Expansion Phase - Arm 215.810.4 – NA
Part B: Dose Expansion Phase - Arm 321.210.5 – NA
Part B: Dose Expansion Phase - Arm 46.93.3 – 11.5
Part B: Dose Expansion Phase - Arm 57.43.3 – 13.4
Part B: Dose Expansion Phase - Arm 68.44.4 – 17.1
Part B: Dose Expansion Phase - Arm 74.12.9 – 5.0
Part B: Dose Expansion Phase - Arm 84.11.2 – 19.5
Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab Secondary · Cycle 4 Day 1 (0 hours and 4 hours) post dose
Cycle 4 Day 1 (Pre-dose)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 123530± 48.02
Part A: Dose Escalation Phase - Cohort 226040± 58.04
Part A: Dose Escalation Phase - Cohort 326160± 23.69
Part A: Dose Escalation Phase - Cohort 430330± 58.28
Part A: Dose Escalation Phase - Cohort 553700± 81.62
Cycle 4 Day 1 (4 h)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 174260± 20.70
Part A: Dose Escalation Phase - Cohort 266250± 47.28
Part A: Dose Escalation Phase - Cohort 369020± 16.47
Part A: Dose Escalation Phase - Cohort 4104300± 35.31
Part A: Dose Escalation Phase - Cohort 5119600± 33.83
Part A: Ctrough Of Pamiparib Secondary · Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)
Cycle 2 Day 1 (Pre-dose)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 1772.9± 164.6
Part A: Dose Escalation Phase - Cohort 21258± 62.13
Part A: Dose Escalation Phase - Cohort 31209± 42.18
Part A: Dose Escalation Phase - Cohort 41876± 60.41
Part A: Dose Escalation Phase - Cohort 52754± 48.69
Cycle 2 Day 1 (7 h)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 1824.8± 130.6
Part A: Dose Escalation Phase - Cohort 21469± 38.14
Part A: Dose Escalation Phase - Cohort 31717± 55.56
Part A: Dose Escalation Phase - Cohort 42070± 47.36
Part A: Dose Escalation Phase - Cohort 52969± 48.77
Part A: Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of Pamiparib Secondary · Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 11457
Part A: Dose Escalation Phase - Cohort 22497
Part A: Dose Escalation Phase - Cohort 32985
Part A: Dose Escalation Phase - Cohort 42586
Part A: Dose Escalation Phase - Cohort 53189
Part A: Time To Reach Maximum Plasma Concentration At Steady State (Tmax,ss) Of Pamiparib Secondary · Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)
GroupValue95% CI
Part A: Dose Escalation Phase - Cohort 11.00.60 – 6.2
Part A: Dose Escalation Phase - Cohort 21.10.42 – 4.0
Part A: Dose Escalation Phase - Cohort 31.01.0 – 7.1
Part A: Dose Escalation Phase - Cohort 41.90.45 – 7.0
Part A: Dose Escalation Phase - Cohort 52.00.92 – 3.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 through 4 years and 7 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Dose Escalation Phase - Cohort 1
Serious: 5/12 (42%)
Deaths: 11/12
Part A: Dose Escalation Phase - Cohort 2
Serious: 5/12 (42%)
Deaths: 9/12
Part A: Dose Escalation Phase - Cohort 3
Serious: 3/6 (50%)
Deaths: 2/6
Part A: Dose Escalation Phase - Cohort 4
Serious: 6/13 (46%)
Deaths: 10/13
Part A: Dose Escalation Phase - Cohort 5
Serious: 5/6 (83%)
Deaths: 3/6
Part B: Dose Expansion Phase - Arm 1a
Serious: 6/23 (26%)
Deaths: 13/23
Part B: Dose Expansion Phase - Arm 1b
Serious: 16/23 (70%)
Deaths: 14/23
Part B: Dose Expansion Phase - Arm 2
Serious: 7/19 (37%)
Deaths: 10/19
Part B: Dose Expansion Phase - Arm 3
Serious: 8/20 (40%)
Deaths: 9/20
Part B: Dose Expansion Phase - Arm 4
Serious: 14/23 (61%)
Deaths: 21/23
Part B: Dose Expansion Phase - Arm 5
Serious: 10/20 (50%)
Deaths: 17/20
Part B: Dose Expansion Phase - Arm 6
Serious: 13/21 (62%)
Deaths: 15/21
Part B: Dose Expansion Phase - Arm 7
Serious: 8/21 (38%)
Deaths: 20/21
Part B: Dose Expansion Phase - Arm 8
Serious: 8/10 (80%)
Deaths: 8/10

Serious adverse events (114 terms)

ReactionSystemPart A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…
Small intestinal obstructionGastrointestinal disorders
Immune-mediated hepatitisHepatobiliary disorders
Spinal cord compressionNervous system disorders
AscitesGastrointestinal disorders
VomitingGastrointestinal disorders
PyrexiaGeneral disorders
HepatitisHepatobiliary disorders
PneumoniaInfections and infestations
Urinary tract infectionInfections and infestations
Acute kidney injuryRenal and urinary disorders
AnaemiaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
DehydrationMetabolism and nutrition disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Lower respiratory tract infectionInfections and infestations
HypophysitisEndocrine disorders
DiarrhoeaGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
Malignant gastrointestinal obstructionGastrointestinal disorders
NauseaGastrointestinal disorders
General physical health deteriorationGeneral disorders
Autoimmune hepatitisHepatobiliary disorders
Malignant biliary obstructionHepatobiliary disorders
Abdominal sepsisInfections and infestations
Other adverse events (96 terms — click to expand)

ReactionSystemPart A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part A: Dose Escalation Ph…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…Part B: Dose Expansion Pha…
NauseaGastrointestinal disorders
FatigueGeneral disorders
DiarrhoeaGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
Aspartate aminotransferase increasedInvestigations
ConstipationGastrointestinal disorders
VomitingGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
Alanine aminotransferase increasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
Upper respiratory tract infectionInfections and infestations
Oedema peripheralGeneral disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
Abdominal painGastrointestinal disorders
ArthralgiaMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
PruritusSkin and subcutaneous tissue disorders
InsomniaPsychiatric disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
DysphagiaGastrointestinal disorders
PyrexiaGeneral disorders
Urinary tract infectionInfections and infestations
AstheniaGeneral disorders
DizzinessNervous system disorders
RashSkin and subcutaneous tissue disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
HypokalaemiaMetabolism and nutrition disorders
HypothyroidismEndocrine disorders
BronchitisInfections and infestations
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
ParaesthesiaNervous system disorders
ThrombocytopeniaBlood and lymphatic system disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
Blood bilirubin increasedInvestigations
Weight decreasedInvestigations
Blood creatine phosphokinase increasedInvestigations
DehydrationMetabolism and nutrition disorders

Most-reported serious reactions: Small intestinal obstruction, Immune-mediated hepatitis, Spinal cord compression, Ascites, Vomiting, Pyrexia, Hepatitis, Pneumonia.

Data from ClinicalTrials.gov NCT02660034 adverse events section.

Sponsor's own description

This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor BGB-290 (pamiparib) in participants with advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
    Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
  2. PARP Inhibitor Upregulates PD-L1 Expression and Enhances Cancer-Associated Immunosuppression.
    Jiao S, Xia W, Yamaguchi H, Wei Y, et al · · 2017 · cited 793× · PMID 28167507 · DOI 10.1158/1078-0432.ccr-16-3215
  3. Exploring treatment options in cancer: Tumor treatment strategies.
    Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7
  4. DNA Damage and Repair Biomarkers of Immunotherapy Response.
    Mouw KW, Goldberg MS, Konstantinopoulos PA, D'Andrea AD. · · 2017 · cited 523× · PMID 28630051 · DOI 10.1158/2159-8290.cd-17-0226
  5. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
    Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
  6. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline <i>BRCA/PALB2</i> Mutation.
    O'Reilly EM, Lee JW, Zalupski M, Capanu M, et al · · 2020 · cited 274× · PMID 31976786 · DOI 10.1200/jco.19.02931
  7. Alterations of DNA damage response pathway: Biomarker and therapeutic strategy for cancer immunotherapy.
    Jiang M, Jia K, Wang L, Li W, et al · · 2021 · cited 236× · PMID 34729299 · DOI 10.1016/j.apsb.2021.01.003
  8. Combining DNA damaging therapeutics with immunotherapy: more haste, less speed.
    Brown JS, Sundar R, Lopez J. · · 2018 · cited 178× · PMID 29123260 · DOI 10.1038/bjc.2017.376

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

Other BeiGene trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02660034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing