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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04215978
Other study ID # BGB-A317-A445-101
Secondary ID 2022-501177-39-0
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date January 30, 2020
Est. completion date September 16, 2024

Study information

Verified date May 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BGB-A445
Administered as specified in the treatment arm
tislelizumab
Administered as specified in the treatment arm

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Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of,  Malaysia,  New Zealand,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1a: Number of Participants Experiencing Adverse Events (AEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Primary Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Primary Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Primary Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445 The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Primary Phase 1b: RP2D of BGB-A445 when Administered Alone Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Primary Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR) Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1a: Duration of Response (DOR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1a: Disease-Control Rate (DCR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1a: Serum Concentration of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Serum Concentration of tislelizumab 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab 60 minutes predose up to 72 hours postdose
Secondary Phase 1a: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445 60 minutes predose up to 21 days postdose
Secondary Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1a: Immunogenic Responses to tislelizumab as assessed through the detection of antidrug antibodies Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator Determined from investigator derived tumor assessments as per RECIST 1.1 Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1b: Duration of Response (DOR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Secondary Phase 1b: Number of Participants Experiencing Adverse Events (AEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Secondary Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Secondary Phase 1b: Serum Concentration of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445 60 minutes predose up to 72 hours postdose
Secondary Phase 1b: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445 60 minutes predose up to 21 days postdose
Secondary Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
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