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

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ClinicalTrials.gov Identifier: NCT04649385
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: BGB-15025 Drug: Tislelizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : August 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1a: Dose Escalation

Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 7 increasing doses

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 )

 Drug: BGB-15025
Administered orally once or twice daily (QD or BID)

Drug: Tislelizumab
Administered 200 mg intravenous (IV) infusion
Other Name: BGB-A317
Experimental: Phase 1b: Dose Expansion
Phase 1b dose expansion will begin based upon the recommended doses for expansion (RDFE) for BGB-15025 alone or in combination with tislelizumab, and with or without chemotherapy as determined from Phase 1a
 Drug: BGB-15025
Administered orally once or twice daily (QD or BID)

Drug: Tislelizumab
Administered 200 mg intravenous (IV) infusion
Other Name: BGB-A317


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1a: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 3 Years ]
    Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.

  2. Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 4 Years ]
  3. Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  4. The maximum tolerated dose (MTD) of BGB-15025 [ Time Frame: Up to 3 Years ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  5. Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy [ Time Frame: Up to 3 years ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  6. RDFE of BGB-15025 in combination with tislelizumab [ Time Frame: Up to 3 years ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  7. Phase 1b: Overall Response Rate (ORR) as assessed by the investigator [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Phase 1a: Overall Response Rate (ORR) as assessed by the investigator [ Time Frame: Up to 3 years ]
  2. Duration Of Response (DOR) as assessed by the investigator [ Time Frame: Up to 3 years ]
  3. Disease Control Rate (DCR) as assessed by the investigator [ Time Frame: Up to 3 years ]
  4. Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  5. Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  6. Phase 1a: Time to maximum plasma concentration (Tmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  7. Phase 1a: Half-life of (t1/2) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  8. Phase 1a: Area under the concentration-time curve (AUC) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  9. Phase 1a: Apparent clearance (CL/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  10. Phase 1a: Apparent volume of distribution (Vz/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  11. Phase 1a: Accumulation Ratio for Cmax of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  12. Phase 1a: Accumulation Ratio for AUC of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  13. Phase 1a: Metabolite to parent ratio for BGB-15025 and its metabolite [ Time Frame: Predose up to 8 hours postdose ]
  14. Phase 1b: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 3 years ]
  15. Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
  16. Phase 1b: Plasma Concentrations of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  17. Phase 1b: Plasma Concentrations of the metabolite [ Time Frame: Predose up to 8 hours postdose ]
  18. Phase 1b: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 1 year ]
    Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease
  3. At least 1 measurable lesion as defined per RECIST 1.1.
  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 treatment: 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

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
  2. Active autoimmune diseases or history of autoimmune diseases that may relapse
  3. Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
  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 treatment
  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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649385


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04649385    
Other Study ID Numbers: BGB-A317-15025-101
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Neoplasms