| Primary | Phase 1A: Number of Participants Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010). | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected maximum tolerated dose (MTD), which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1A: Number Of Participants With Abnormal Physical Examination Values | A complete physical examination, vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1A. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required. | Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months) | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1A. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment. | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day 15 of cycle 1, Day 1 of Cycle 2 and all additional cycles, and 30 (+/- 7) days after last dose (up to 5 years and 2 months) | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1A: Number Of Participants With Abnormal Electrocardiograms | Electrocardiograms were obtained at pre-specified time points. Significant QT interval corrected for heart rate (QTc) prolongation was defined as an interval ≥ 500 milliseconds (msec) or an interval which increases by ≥ 60 msec over baseline. | Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed | Posted | | Count of Participants | | Participants | | Days 1 and 15 of cycle 1; Day 1 of cycle 2 and all additional cycles; Day 1 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months) | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1A: Number Of Participants With Abnormal Laboratory Values | Clinical chemistry, hematology, coagulation, and urinalysis were performed at pre-specified time points for Phase 1A. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to ≥ Grade 3 are reported. | Safety Analysis Set: participants who had received any dose of tislelizumab and with baseline assessment and at least one post-baseline assessment. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 (predose), Days 1, 8, and 15 of cycle 1; Days 1 and 15 of cycle 2 and additional cycles; Days 1 and 15 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months) | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1A: Number Of Participants Experiencing Severe AEs | All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and serious adverse event (SAE) recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe. | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Primary | Phase 1B: Objective Response Rate (ORR) | The ORR was defined as the percentage of participants in the study whose best overall response was either complete response (CR) or partial response (PR) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. | Efficacy Evaluable Set (EFF) included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab | | PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | Posted | | Mean | Standard Deviation | micrograms/milliliter*day | | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG001 | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG002 | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. |
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| Secondary | Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab | | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | Posted | | Mean | Standard Deviation | micrograms/milliliter | | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG001 | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG002 | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | |
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| Secondary | Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab | | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | Posted | | Mean | Standard Deviation | hours | | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W). until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG001 | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG002 | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG003 |
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| Secondary | Phase 1A: Half-life (T½) For Tislelizumab | | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | Posted | | Mean | Standard Deviation | hours | | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | Participants were dosed at 0.5 milligrams/kilograms (mg/kg), tislelizumab, once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG001 | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | Participants were dosed at 2.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG002 | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | Participants were dosed at 5.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG003 |
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| Secondary | Phase 1A - Part 3: Clearance (Cl) For Tislelizumab | | PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. per-pre-specification, data was analyzed only for Part 3 of Phase 1A. | Posted | | Geometric Mean | 95% Confidence Interval | liters/day | | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg | Participants received selected maximum tolerated dose of 200.0 mg/kg tislelizumab, Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A/1B: Number Of Participants With Anti-drug Antibodies (ADAs) | Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs, which included positive ADAs and neutralizing antibodies (NAb). | Evaluable set: participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. | Posted | | Number | | Participants | | Day 1 of Cycles 1 through 15 | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | Participants were dosed at 0.5 milligrams/kilograms (mg/kg), once every 2 weeks (Q2W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG001 | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | Participants were dosed at 2.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. | | OG002 | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | Participants were dosed at 5.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration |
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| Secondary | Phase 1A: ORR | The ORR was defined as the percentage of participants in the study whose best overall response was either CR or PR as assessed by investigators based on RECIST v 1.1. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: CR Rate | The CR rate was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: PR Rate | The PR rate was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: Stable Disease (SD) Rate | The SD rate was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: Progression-free Survival (PFS) | PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Median | 95% Confidence Interval | months | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: Overall Survival (OS) | OS was defined as the time interval between the date of the first study drug dose to the date of death for any cause. Kaplan-Meier methodology was used to estimate OS at various time points. The OS was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Median | 95% Confidence Interval | months | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1A: Duration Of Response (DOR) | DOR for responders (CR or PR) was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease or death for any cause, whichever occurred earlier. For participants who were alive without progression following the qualifying response, DOR was censored on the date of last evaluable tumor assessment or last follow-up for progression of disease. The DOR was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Posted | | Median | 95% Confidence Interval | months | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which was 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number of Participants Experiencing AEs | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product. All AEs were monitored per the NCI-CTCAE (v 4.03 2010). | Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab | | PK Analysis Set included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter | | Pre-dose, Day 1 Cycle 5 and every other Cycle in the first 6 months, every 4 cycles in the next 6 months, once every 6 months up to end of treatment (up to 5 years and 2 months) | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: PFS | PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. | Posted | | Median | 95% Confidence Interval | months | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Disease Control Rate (DCR) | The DCR was defined as the percentage of participants who achieve CR, PR, and SD based on RECIST v 1.1 in participants with select tumor types. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of participants who achieved CR, PR, and durable SD [SD ≥24 weeks] based on RECIST v 1.1 in participants with select tumor types. | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number Of Participants With Abnormal Physical Examination Values | A complete physical examination, vital signs (SBP, DBP, pulse rate, temperature, and respiratory rate), and weight were performed pre-specified time points for Phase 1B. During the treatment period, symptom-directed physical examinations were performed. If there were no complaints and no abnormal findings from the previous visit for a particular organ system, a physical examination of that organ system was not required. | Safety Analysis Set: all participants who had received any dose of tislelizumab and with baseline. | Posted | | Count of Participants | | Participants | | Day -28 (predose), Days 1, 4, 8, and 15 of cycle 1; Day 1 of cycle 2; through 30 (+/- 7) days after last dose up to 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | Ophthalmological examinations (such as eyesight/visual acuity, fundoscopy, slit lamp microscopy, and optical coherence tomography [or equivalent diagnostic test]) were performed at pre-specified time points for Phase 1B. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) will be assessed by an appropriate specialist at Screening. Participants dosed underwent subsequent ophthalmologic examinations, a specified in the protocol, by an appropriate specialist during study treatment. | Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab. | Posted | | Count of Participants | | Participants | | Day -28 (predose), Day 1 of cycle 2 and additional cycles, and 30 (+/- 7) days after last dose up to 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number Of Participants With Abnormal Electrocardiograms | Electrocardiograms were obtained at pre-specified time points. Significant QTc prolongation was defined as an interval ≥ 500 msec or an interval which increases by ≥ 60 msec over baseline. | Safety Analysis Set: all participants who had received any dose of tislelizumab. | Posted | | Count of Participants | | Participants | | Day -28 (predose), Days 1 and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number Of Participants With Abnormal Laboratory Values | Clinical chemistry, hematology, coagulation, and urinalysis will be performed at pre-specified time points for Phase 1A and Phase 1B respectively. If warranted, additional testing was done, or the relevant tests done more frequently in accordance with institutional guidelines. All participants who had any Grade 3 or Grade 4 laboratory abnormalities at withdrawal from the study were followed up until they had returned to Grade 1 or Grade 2, unless these were not likely to improve due to the underlying disease. Participants experiencing decreases (low) and increases (high) to ≥ Grade 3 are reported. | Safety Analysis Set: participants who had received any dose of tislelizumab. | Posted | | Count of Participants | | Participants | | Day -28 (predose), Days 1, 8, and 15 of cycle 1; Day 1 of cycle 2 and additional cycles; 30 (+/- 7) days after last dose up to 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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| Secondary | Phase 1B: Number Of Participants Experiencing Severe AEs | All AEs were monitored per the NCI-CTCAE (v 4.03 2010). In addition to performing the CTCAE assessment, the intensity of each AE and SAE recorded was assigned to one of the following categories based on the Investigator's clinical judgment: Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate: An event that is sufficiently discomforting to interfere with normal everyday activities; severe: An event that prevents normal everyday activities. Severity was a category utilized for rating the intensity of an event and, accordingly, both AEs and SAEs could be assessed as severe. | Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab. | Posted | | Count of Participants | | Participants | | Day -28 through 5 years and 2 months | | | | ID | Title | Description |
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| OG000 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. |
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