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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 : November 3, 2021
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 : 240 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 : August 2023
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 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

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

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 Phase 2 dose (RP2D) for BGB-15025 alone or in combination with tislelizumab as determined from Phase 1a
 Drug: BGB-15025
Administered orally once daily (QD)

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 6 months ]
  2. Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months ]
  3. 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%

  4. 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%

  5. 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%


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  2. Duration Of Response (DOR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  3. Disease Control Rate (DCR) as assessed by the investigator [ Time Frame: Up to 6 months ]
  4. Maximum observed plasma concentration (Cmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  5. Minimum observed plasma concentration (Cmin) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  6. Time to maximum plasma concentration (Tmax) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  7. Half-life of (t1/2) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  8. Area under the concentration-time curve (AUC) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  9. Apparent clearance (CL/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]
  10. Apparent volume of distribution (Vz/F) of BGB-15025 [ Time Frame: Predose up to 8 hours postdose ]

Eligibility Criteria
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Information from the National Library of Medicine

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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. 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.

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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United States, New York
One Gustave L Levy Place Recruiting
New York, New York, United States, 10029
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Timothy Yap    713-563-1784      
Contact: tyap@mdanderson.org         
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Windsor, South Australia, Australia, 5037
Contact: Gonzalo T Rico         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Peter Lau, MD         
New Zealand
ADHB, Cancer & Blood Research - Auckland Cancer Trials Centre Recruiting
Grafton, Auckland, New Zealand, 1023
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: November 3, 2021
Last Verified: November 2021
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