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Completed

NCT Number: NCT04649385

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prince of Wales Hospital, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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
  • Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, and metastatic including non-small cell lung cancer, and gastric/Gastroesophageal junction cancer that have no prior systemic treatment for advanced disease and esophageal squamous cancer who have progressed following systemic anticancer therapies
  • At least 1 measurable lesion as defined per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • 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 10^9/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:

  • Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • 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
  • 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
  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
  • For Cohort A: Known actionable mutations (including but not limited to epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, RET, MET, and ROS1, for which a targeted therapy has been approved by the local health authority and available.
  • For Cohort B: Diagnosed with G/GEJ adenocarcinoma with positive HER2 status

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

Treatment and study plan

BGB-15025

Drug

Administered orally once or twice daily (QD or BID)

Tislelizumab

Drug

Administered 200 mg intravenous (IV) infusion

Other names: BGB-A317

carboplatin

Drug

Administered intravenously

Cisplatin

Drug

Administered intravenously

Pemetrexed

Drug

Administered intravenously

Oxaliplatin

Drug

Administered intravenously

Capecitabine

Drug

Administered intravenously

paclitaxel

Drug

Administered intravenously

Nab-paclitaxel

Drug

Administered intravenously

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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