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New drug combo shows promise in early cancer trial

NCT ID NCT04649385

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called BGB-15025, alone or with another drug (tislelizumab), in 157 people with advanced solid tumors that had stopped responding to standard treatments. The main goal was to check safety and find the best dose. The study is now complete, and results will help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-15025 (HPK1 inhibitor) and tislelizumab (anti-PD-1 antibody)
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the drug works. Side effects are possible, and the drug may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

157 people

The number who actually took part.

Started

Mar 2021

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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 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 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: 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. 6. 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. 7. For Cohort B: Diagnosed with G/GEJ adenocarcinoma with positive HER2 status NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Ashford Cancer Centre Research Northeast

    Windsor Gardens, South Australia, SA 5087, Australia

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029-6504, United States

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, NSW 2031, Australia

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

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

    Hangzhou, Zhejiang, 310016, China

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229-4427, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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