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

Trial Status: Active

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.

Inclusion Criteria

  • 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
  • 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
  • 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
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • 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 )

Exclusion Criteria

  • 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)
  • Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
  • Controlled Type 1 diabetes
  • Hypothyroidism (provided that it is managed with hormone-replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors
  • 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)
  • 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:
  • Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
  • Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
  • 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)
  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Timothy Anthony Yap
Phone: 713-563-1784

Trial Phase Phase I

Trial Type Treatment

Lead Organization
BeiGene

  • Primary ID BGB-A317-15025-101
  • Secondary IDs NCI-2021-03010
  • Clinicaltrials.gov ID NCT04649385