Trial Outcomes & Findings for Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors (NCT NCT02407990)

Last Updated: 2021-11-17

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

451 participants

Primary outcome timeframe

Day -28 through 5 years and 2 months

Results posted on

2021-11-17

Participant Flow

This study was conducted in 27 centers in 5 countries, enrolled from June 2015 to October 2017 across both Phases, and was initiated in June 2015. After a 5-year period the sponsor decided to close the study as primary and secondary endpoints were met. Participants still on treatment were rolled into a separate long-term extension study (BGB-A317-290-LTE1) to continue treatment.

Participant milestones

Participant milestones
Measure	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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.	BGB-A317 Phase 1B Participants were dosed at 5 mg/kg tislelizumab, Q3W until confirmed disease progression, intolerable toxicity, subject 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.
Overall Study STARTED	3	26	26	7	21	20	13	335
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	26	26	7	21	20	13	335

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.	BGB-A317 Phase 1B Participants were dosed at 5 mg/kg tislelizumab, Q3W until confirmed disease progression, intolerable toxicity, subject 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.
Overall Study Death	2	22	23	7	17	16	10	248
Overall Study Lost to Follow-up	0	1	0	0	0	0	0	17
Overall Study Progressive Disease	0	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	0	1	0	0	30
Overall Study Study Terminated by Sponsor	1	3	3	0	3	4	3	37
Overall Study Logistics	0	0	0	0	0	0	0	1
Overall Study Rolled into long-term extension study	0	0	0	0	0	0	0	1

Baseline Characteristics

Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=26 Participants 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	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=26 Participants 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	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=7 Participants Participants were dosed at 10.0 mg/kg, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=21 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=20 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=13 Participants Participants received selected maximum tolerated dose of 200.0 mg/kg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1B n=335 Participants Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, subject 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.	Total n=451 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 7.02 • n=5 Participants	59.1 years STANDARD_DEVIATION 11.15 • n=7 Participants	57.8 years STANDARD_DEVIATION 13.32 • n=5 Participants	57.1 years STANDARD_DEVIATION 8.13 • n=4 Participants	63.6 years STANDARD_DEVIATION 10.09 • n=21 Participants	62.6 years STANDARD_DEVIATION 11.14 • n=8 Participants	58.4 years STANDARD_DEVIATION 17.76 • n=8 Participants	59.5 years STANDARD_DEVIATION 11.92 • n=24 Participants	59.6 years STANDARD_DEVIATION 11.96 • n=42 Participants
Age, Customized < 65 Years	3 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	11 Participants n=8 Participants	6 Participants n=8 Participants	217 Participants n=24 Participants	285 Participants n=42 Participants
Age, Customized ≥ 65 Years	0 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants	9 Participants n=8 Participants	7 Participants n=8 Participants	118 Participants n=24 Participants	166 Participants n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	12 Participants n=8 Participants	5 Participants n=8 Participants	144 Participants n=24 Participants	205 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	191 Participants n=24 Participants	246 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	8 Participants n=24 Participants	10 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants	20 Participants n=8 Participants	13 Participants n=8 Participants	322 Participants n=24 Participants	436 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	120 Participants n=24 Participants	130 Participants n=42 Participants
Race/Ethnicity, Customized Chinese (enrolled from Taiwan sites)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	61 Participants n=24 Participants	61 Participants n=42 Participants
Race/Ethnicity, Customized Non-Chinese	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	59 Participants n=24 Participants	69 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	7 Participants n=4 Participants	19 Participants n=21 Participants	16 Participants n=8 Participants	11 Participants n=8 Participants	189 Participants n=24 Participants	290 Participants n=42 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	18 Participants n=24 Participants	23 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: 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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number of Participants Experiencing Adverse Events (AEs)	114 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≥ 160 mmHg	17 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline pulse rate measure ≤ 45 beats per minute (bpm)	1 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline pulse rate measure ≥ 120 bpm	6 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≤ 60 millimeters of mercury (mmHg)	0 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≤ 90 mmHg	9 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline DBP measure ≥ 100 mmHg	5 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QT corrected using Fridericia's formula (QTcF) Interval measure of >450 msec	31 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure of > 480 msec	9 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure of > 500 msec	3 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure ≤ 30 msec increase from baseline	73 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure ≤ 30 and ≤ 60 msec increase from baseline	35 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure > 60 msec increase from baseline	8 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number Of Participants With Abnormal Laboratory Values Alanine Aminotransferase: High	6 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Albumin: Low	11 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Alkaline Phosphatase: High	7 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Aspartate Aminotransferase: High	5 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Bilirubin: High	7 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Calcium: Low	7 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Calcium: High	2 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Creatinine: High	6 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Glucose: Low	5 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Glucose: High	13 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Hemoglobin: Low	6 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Leukocytes: Low	3 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Leukocytes: High	0 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Lymphocytes: Low	22 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Lymphocytes: High	2 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Neutrophils: Low	2 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Phosphate: Low	19 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Platelets: Low	1 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Potassium: Low	21 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Potassium: High	7 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Sodium: Low	8 Participants	—	—	—	—	—	—
Phase 1A: Number Of Participants With Abnormal Laboratory Values Sodium: High	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day -28 through 5 years and 2 months

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Number Of Participants Experiencing Severe AEs	14 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Objective Response Rate (ORR)	11.6 percentage of participants Interval 8.41 to 15.57	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=6 Participants Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=18 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=20 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=12 Participants 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.
Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab	84.92 micrograms/milliliter*day Standard Deviation 35.90	332.2 micrograms/milliliter*day Standard Deviation 57.33	811.8 micrograms/milliliter*day Standard Deviation 239.5	1916.0 micrograms/milliliter*day Standard Deviation 458.5	512.1 micrograms/milliliter*day Standard Deviation 122.2	1219.0 micrograms/milliliter*day Standard Deviation 287.4	674.7 micrograms/milliliter*day Standard Deviation 173.6

SECONDARY outcome

Timeframe: 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

Population: PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=6 Participants Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=18 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=20 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=12 Participants 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.
Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab	13.5 micrograms/milliliter Standard Deviation 3.80	48.3 micrograms/milliliter Standard Deviation 6.89	147.0 micrograms/milliliter Standard Deviation 50.8	278.0 micrograms/milliliter Standard Deviation 53.7	56.8 micrograms/milliliter Standard Deviation 12.8	130.0 micrograms/milliliter Standard Deviation 29.7	77.2 micrograms/milliliter Standard Deviation 13.9

SECONDARY outcome

Timeframe: 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

Population: PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=6 Participants Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=18 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=20 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=12 Participants 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.
Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab	3.46 hours Standard Deviation 3.12	2.39 hours Standard Deviation 0.89	2.48 hours Standard Deviation 0.73	2.43 hours Standard Deviation 1.83	1.57 hours Standard Deviation 0.65	4.95 hours Standard Deviation 15.4	1.40 hours Standard Deviation 0.82

SECONDARY outcome

Timeframe: 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

Population: PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=6 Participants 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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=6 Participants Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=18 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=20 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=12 Participants 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.
Phase 1A: Half-life (T½) For Tislelizumab	10.7 hours Standard Deviation 3.90	12.9 hours Standard Deviation 1.2	15.0 hours Standard Deviation 14.4	14.5 hours Standard Deviation 4.04	17.1 hours Standard Deviation 8.14	19.6 hours Standard Deviation 7.63	16.8 hours Standard Deviation 5.50

SECONDARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=12 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A - Part 3: Clearance (Cl) For Tislelizumab	0.186 liters/day Interval 0.135 to 0.256	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 through 15

Population: Evaluable set: participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.

Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs, which included positive ADAs and neutralizing antibodies (NAb).

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=3 Participants 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.	BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg n=21 Participants 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.	BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg n=25 Participants 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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg n=6 Participants Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg n=19 Participants Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg n=285 Participants Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg n=11 Participants 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.
Phase 1A/1B: Number Of Participants With Anti-drug Antibodies (ADAs)	1 Participants	6 Participants	5 Participants	1 Participants	6 Participants	43 Participants	3 Participants

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: ORR	18.1 percentage of participants Interval 11.57 to 26.33	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

The CR rate was based on RECIST v 1.1 and the results of Investigator evaluations.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: CR Rate	6 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

The PR rate was based on RECIST v 1.1 and the results of Investigator evaluations.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: PR Rate	15 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

The SD rate was based on RECIST v 1.1 and the results of Investigator evaluations.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Stable Disease (SD) Rate	42 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Progression-free Survival (PFS)	3.5 months Interval 2.1 to 3.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Overall Survival (OS)	13.6 months Interval 9.9 to 17.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=116 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1A: Duration Of Response (DOR)	14.6 months Interval 8.3 to NA = Not estimable due to insufficient number of participants with events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number of Participants Experiencing AEs	322 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=145 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Esophageal Carcinoma	57.8 micrograms/milliliter Geometric Coefficient of Variation 62.4	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Triple Negative Breast Cancer	47.8 micrograms/milliliter Geometric Coefficient of Variation 78.9	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Non-Small Cell Lung Cancer	63.9 micrograms/milliliter Geometric Coefficient of Variation 47.8	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Ovarian Cancer	90.4 micrograms/milliliter Geometric Coefficient of Variation 66.7	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Gastric Cancer	40.7 micrograms/milliliter Geometric Coefficient of Variation 91.4	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Hepatocellular Carcinoma	54.4 micrograms/milliliter Geometric Coefficient of Variation 56.8	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Head & Neck Squamous Cell Carcinoma	77.4 micrograms/milliliter Geometric Coefficient of Variation 45.8	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Cholangio Carcinoma	65.7 micrograms/milliliter Geometric Coefficient of Variation 47.9	—	—	—	—	—	—
Phase 1B: Steady State Plasma Trough Concentration Of Tislelizumab Other Solid Tumors	80.4 micrograms/milliliter Geometric Coefficient of Variation 43.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: PFS	2.1 months Interval 2.0 to 2.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Disease Control Rate (DCR)	41.2 percentage of participants Interval 35.87 to 46.67	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Clinical Benefit Rate (CBR)	24.5 percentage of participants Interval 19.97 to 29.45	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Analysis Set: all participants who had received any dose of tislelizumab and with baseline.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline pulse rate measure ≤ 45 bpm	5 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline pulse rate measure ≥ 120 bpm	26 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≤ 60 mmHg	1 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≤ 90 mmHg	24 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline SBP measure ≥ 160 mmHg	30 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Physical Examination Values At least one postbaseline DBP measure ≥ 100 mmHg	12 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Analysis Set: all participants who had received any dose of tislelizumab.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure >30 and ≤ 60 msec increase from baseline	67 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure > 450 msec	84 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure > 480 msec	24 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure > 500 msec	10 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure ≤ 30 msec increase from baseline	241 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Electrocardiograms At least 1 postbaseline QTcF Interval measure > 60 msec increase	22 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: Safety Analysis Set: participants who had received any dose of tislelizumab.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number Of Participants With Abnormal Laboratory Values Alanine Aminotransferase: High	21 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Albumin: Low	42 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Alkaline Phosphatase: High	21 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Aspartate Aminotransferase: High	21 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Bilirubin: High	22 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Calcium: Low	12 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Calcium: High	7 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Creatinine: High	20 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Glucose: Low	8 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Glucose: High	32 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Hemoglobin: Low	19 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Leukocytes: Low	8 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Leukocytes: High	1 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Lymphocytes: Low	33 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Lymphocytes: High	2 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Neutrophils: Low	5 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Phosphate: Low	42 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Platelets: Low	3 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Potassium: Low	35 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Potassium: High	4 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Sodium: Low	25 Participants	—	—	—	—	—	—
Phase 1B: Number Of Participants With Abnormal Laboratory Values Sodium: High	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -28 through 5 years and 2 months

Population: Safety Analysis Set (SAF) included all patients who had received any dose of tislelizumab.

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.

Outcome measures

Outcome measures
Measure	BGB-A317 Phase 1A n=335 Participants 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.	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.	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.	BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg Participants were dosed at 10.0 mg/kg tislelizumab, Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration.	BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg Participants received selected dosing based on Part 1 of 2.0 mg/kg tislelizumab, once every 3 weeks (Q3W) until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg Participants received selected dosing based on Part 1 of 5.0 mg/kg tislelizumab,Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 21 days in duration.	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.
Phase 1B: Number Of Participants Experiencing Severe AEs	27 Participants	—	—	—	—	—	—

Adverse Events

BGB-A317 Phase 1A

Serious events: 40 serious events

Other events: 112 other events

Deaths: 97 deaths

BGB-A317 Phase 1B

Serious events: 131 serious events

Other events: 302 other events

Deaths: 249 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER