Trial · NCT02407990
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
NCT02407990, Phase 1, Completed, BeiGene; results first posted 2021-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors. Trials, record NCT02407990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02407990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
- NCT number
- NCT02407990
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 451 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Advanced Cancer
- Interventions
- BGB-A317, BGB-A317
- First posted
- 2015-04-03
- Last updated
- 2021-11-17
- Results first posted
- 2021-11-17
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1A: Number of Participants Experiencing Adverse Events (AEs) | Day -28 through 5 years and 2 months | 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). |
| Primary | Phase 1A: Number Of Participants With Abnormal Physical Examination Values | Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months) | 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. |
| Primary | Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | 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. |
| Primary | Phase 1A: Number Of Participants With Abnormal Electrocardiograms | 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. |
| Primary | Phase 1A: Number Of Participants With Abnormal Laboratory Values | 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) | 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. |
| Primary | Phase 1A: Number Of Participants Experiencing Severe AEs | 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. |
| Primary | Phase 1B: Objective Response Rate (ORR) | Day -28 through 5 years and 2 months | 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. |
| Secondary | Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab | 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 | |
| Secondary | Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab | 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 | |
| Secondary | Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab | 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 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1A: Number of Participants Experiencing Adverse Events (AEs) | Day -28 through 5 years and 2 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Physical Examination Values | Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Electrocardiograms | 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) | 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 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Laboratory Values | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants Experiencing Severe AEs | Day -28 through 5 years and 2 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1B: Objective Response Rate (ORR) | Day -28 through 5 years and 2 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab | 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 | 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. | micrograms/milliliter*day | MEAN |
| SECONDARY | Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab | 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 | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | micrograms/milliliter | MEAN |
| SECONDARY | Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab | 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 | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | hours | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1A: Number of Participants Experiencing Adverse Events (AEs) | BGB-A317 Phase 1A | 114 | Participants | ||
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline pulse rate measure ≤ 45 beats per minute (bpm) | 1 | Participants | |
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline pulse rate measure ≥ 120 bpm | 6 | Participants | |
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline SBP measure ≤ 60 millimeters of mercury (mmHg) | 0 | Participants | |
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline SBP measure ≤ 90 mmHg | 9 | Participants | |
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline SBP measure ≥ 160 mmHg | 17 | Participants | |
| Phase 1A: Number Of Participants With Abnormal Physical Examination Values | BGB-A317 Phase 1A | At least one postbaseline DBP measure ≥ 100 mmHg | 5 | Participants | |
| Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | BGB-A317 Phase 1A | 0 | Participants | ||
| Phase 1A: Number Of Participants With Abnormal Electrocardiograms | BGB-A317 Phase 1A | 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 | BGB-A317 Phase 1A | At least 1 postbaseline QTcF Interval measure of > 480 msec | 9 | Participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | 3 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | 26 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 1 - 5.0 mg/kg | 26 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 1 - 10.0 mg/kg | 7 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 2 - 2.0 mg/kg | 21 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 2 - 5.0 mg/kg | 20 | |
| Overall Study | STARTED | BGB-A317 Phase 1A - Part 3 - 200.0 mg/kg | 13 | |
| Overall Study | STARTED | BGB-A317 Phase 1B | 335 | |
| Overall Study | COMPLETED | BGB-A317 Phase 1A - Part 1 - 0.5 mg/kg | 0 | |
| Overall Study | COMPLETED | BGB-A317 Phase 1A - Part 1 - 2.0 mg/kg | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events430
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | BGB-A317 Phase 1A | 41 | 116 | |
| other | Nausea | Gastrointestinal disorders | BGB-A317 Phase 1B | 71 | 335 | |
| other | Diarrhoea | Gastrointestinal disorders | BGB-A317 Phase 1A | 33 | 116 | |
| other | Diarrhoea | Gastrointestinal disorders | BGB-A317 Phase 1B | 49 | 335 | |
| other | Constipation | Gastrointestinal disorders | BGB-A317 Phase 1A | 28 | 116 | |
| other | Constipation | Gastrointestinal disorders | BGB-A317 Phase 1B | 51 | 335 | |
| other | Abdominal pain | Gastrointestinal disorders | BGB-A317 Phase 1A | 25 | 116 | |
| other | Abdominal pain | Gastrointestinal disorders | BGB-A317 Phase 1B | 42 | 335 | |
| other | Vomiting | Gastrointestinal disorders | BGB-A317 Phase 1A | 19 | 116 | |
| other | Vomiting | Gastrointestinal disorders | BGB-A317 Phase 1B | 42 | 335 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BGB-A317 Phase 1A | 97 | 116 |
| Total, all-cause mortality | BGB-A317 Phase 1B | 249 | 335 |
| Total, other adverse events | BGB-A317 Phase 1A | 112 | 116 |
| Total, other adverse events | BGB-A317 Phase 1B | 302 | 335 |
| Total, serious adverse events | BGB-A317 Phase 1A | 40 | 116 |
| Total, serious adverse events | BGB-A317 Phase 1B | 131 | 335 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BGB-A317 Phase 1A vs BGB-A317 Phase 1B: deaths from any cause | Trial comparisons |
| BGB-A317 Phase 1A vs BGB-A317 Phase 1B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02407990
GET https://conductscience.org/api/trials/v1/NCT02407990/registered?page=2