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Advanced Solid TumorPhase 1NCT04649385

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

A Phase 1 study testing BGB-15025, Tislelizumab and Carboplatin in people with Advanced Solid Tumor, run by BeiGene at 20 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
BGB-15025, Tislelizumab and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
20 sitesin 5 countries
Study dates
4 Mar 2021to 15 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

China7 sites
  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

South Korea5 sites
  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

Other trials in South Korea

Australia4 sites
  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

  • Prince of Wales Hospital

    Randwick, New South Wales, NSW 2031

  • Ashford Cancer Centre Research Northeast

    Windsor Gardens, South Australia, SA 5087

Other trials in Australia

United States3 sites
  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029-6504

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229-4427

Other trials in United States

New Zealand1 site
  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

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

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.

Being tested
BGB-15025, Tislelizumab, Carboplatin, Cisplatin, Pemetrexed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04649385
Study groupRoleWhat they receive
Phase 1a: Dose EscalationExperimentalPart 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 )
Receives: Drug: BGB-15025; Drug: Tislelizumab
Phase 1b: Dose ExpansionExperimentalPhase 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
Receives: Drug: BGB-15025; Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Paclitaxel; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Number of participants with dose limiting toxicities (DLTs)

    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.

    Measured: Up to 3 Years

  2. Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to 4 Years

  3. Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to 4 years

  4. The maximum tolerated dose (MTD) of BGB-15025

    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

    Measured: Up to 3 Years

  5. Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy

    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

    Measured: Up to 3 years

  6. RDFE of BGB-15025 in combination with tislelizumab

    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

    Measured: Up to 3 years

  7. Phase 1b: Overall Response Rate (ORR) as assessed by the investigator

    Measured: Up to 2 years

Secondary outcomes (18)
  1. Phase 1a: Overall Response Rate (ORR) as assessed by the investigator

    Measured: Up to 3 years

  2. Duration Of Response (DOR) as assessed by the investigator

    Measured: Up to 3 years

  3. Disease Control Rate (DCR) as assessed by the investigator

    Measured: Up to 3 years

  4. Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025

    Measured: Predose up to 8 hours postdose

  5. Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025

    Measured: Predose up to 8 hours postdose

  6. Phase 1a: Time to maximum plasma concentration (Tmax) of BGB-15025

    Measured: Predose up to 8 hours postdose

  7. Phase 1a: Half-life of (t1/2) of BGB-15025

    Measured: Predose up to 8 hours postdose

  8. Phase 1a: Area under the concentration-time curve (AUC) of BGB-15025

    Measured: Predose up to 8 hours postdose

  9. Phase 1a: Apparent clearance (CL/F) of BGB-15025

    Measured: Predose up to 8 hours postdose

  10. Phase 1a: Apparent volume of distribution (Vz/F) of BGB-15025

    Measured: Predose up to 8 hours postdose

  11. Phase 1a: Accumulation Ratio for Cmax of BGB-15025

    Measured: Predose up to 8 hours postdose

  12. Phase 1a: Accumulation Ratio for AUC of BGB-15025

    Measured: Predose up to 8 hours postdose

  13. Phase 1a: Metabolite to parent ratio for BGB-15025 and its metabolite

    Measured: Predose up to 8 hours postdose

  14. Phase 1b: Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to 3 years

  15. Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to 3 years

  16. Phase 1b: Plasma Concentrations of BGB-15025

    Measured: Predose up to 8 hours postdose

  17. Phase 1b: Plasma Concentrations of the metabolite

    Measured: Predose up to 8 hours postdose

  18. Phase 1b: Number of participants with dose limiting toxicities (DLTs)

    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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start4 Mar 2021
  3. Primary completion17 Oct 2025
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649385
Sponsor's protocol ID
BGB-A317-15025-101
Other IDs
CTR20212721
Status last verified
Jun 2026
First submitted
25 Nov 2020
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-15025, Tislelizumab and Carboplatin in people with Advanced Solid Tumor, run by BeiGene at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China, South Korea, Australia, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of participants with dose limiting toxicities (DLTs) (time frame: Up to 3 Years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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