Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A317-15025-101
Previous Study | Return to List | Next Study

BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649385
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE November 25, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE March 4, 2021
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2020)
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 6 months ]
  • Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months ]
  • The maximum tolerated dose (MTD) of BGB-15025 [ Time Frame: Up to 6 months ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
  • RP2D of BGB-15025 monotherapy [ Time Frame: Up to 6 months ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
  • RP2D of BGB-15025 in combination with tislelizumab [ Time Frame: Up to 6 months ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2020)
  • Overall Response Rate (ORR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  • Duration Of Response (DOR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  • Disease Control Rate (DCR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  • Maximum observed plasma concentration (Cmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Minimum observed plasma concentration (Cmin) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Time to maximum plasma concentration (Tmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Half-life of (t1/2) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Area under the concentration-time curve (AUC) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Apparent clearance (CL/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  • Apparent volume of distribution (Vz/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Brief Summary The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Drug: BGB-15025
    Administered orally once daily (QD)
  • Drug: Tislelizumab
    Administered 200 mg intravenous (IV) infusion
    Other Name: BGB-A317
Study Arms  ICMJE
  • Experimental: Phase 1a: Dose Escalation

    Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 5 increasing doses for up to 6 months

    Part B: Participants will receive once daily of BGB-15025 in sequential cohorts plus 200mg tislelizumab on day 1 of each 21-day cycle (combination therapy ) for up to 12 months

    Interventions:
    • Drug: BGB-15025
    • Drug: Tislelizumab
  • Experimental: Phase 1b: Dose Expansion
    Phase 1b dose expansion will begin based upon the recommended Phase 2 dose (RP2D) for BGB-15025 alone or in combination with tislelizumab as determined from Phase 1a
    Interventions:
    • Drug: BGB-15025
    • Drug: Tislelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2020)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1
  2. At least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s) selected have not been previously treated with local therapy or the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST 1.1
  3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample (block or approximately 15 to 17 freshly unstained FFPE slides after the most recent line of therapy. If archival tissue is not available, fresh tumor biopsy is mandatory
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  5. Adequate organ function as indicated by the following laboratory values up to first dose of study drug: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN (≤5 x ULNs for participants with hepatocellular carcinoma or liver metastases )

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s)
  2. Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:

    1. Controlled Type 1 diabetes
    2. Hypothyroidism (provided that it is managed with hormone-replacement therapy only)
    3. Controlled celiac disease
    4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
    5. Any other disease that is not expected to recur in the absence of external triggering factors
  3. Any active malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
  4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions:

    1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
    2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
    3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
  5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04649385
Other Study ID Numbers  ICMJE BGB-A317-15025-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xiusong Qiu, MD BeiGene
PRS Account BeiGene
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP