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New drug cocktail shows promise for Hard-to-Treat cancers

NCT ID NCT04282018

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called BGB-10188, alone or combined with other cancer drugs (zanubrutinib for blood cancers, tislelizumab for solid tumors), in 97 patients whose cancers had returned or stopped responding to treatment. The main goals were to find safe doses and check for side effects. The study did not fully determine the best dose, but it gathered important safety information for 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-10188 (a PI3Kδ inhibitor) combined with zanubrutinib or tislelizumab
What this could lead to
If successful, this could lead to a new treatment option for certain blood cancers and solid tumors that have not responded to prior therapy.
What could go wrong
This is an early-phase trial with only 97 participants, and the recommended dose was not fully determined. Side effects are possible, and the combinations may not prove effective in larger studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

97 people

The number who actually took part.

Started

Apr 2020

Finished

Aug 2024

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: Parts A, B and C 1. Confirmed diagnosis of one of the following: * Part A: R/R CLL/SLL, R/R MZL, R/R FL, R/R MCL or R/R DLBCL * Part B: R/R FL, R/R MCL, or R/R DLBCL * Part C: R/R FL, R/R MCL, or R/R DLBCL CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; MZL = marginal zone lymphoma 2. Participants with MZL, FL, MCL, DLBCL, or SLL must have had at least one bi-dimensionally measurable nodal lesion greater than (\>) 1.5 centimeters (cm) in the longest diameter or extranodal lesion that is \> 1 cm in the longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Lugano Classification. Parts D and E 3. Part D: Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy (including prior chemotherapy, radiotherapy, target therapy, and immunotherapy as locally, or guidance approved therapy) or for which treatment is not available or not tolerated. Enrollment was limited to participants with advanced solid tumors for which there was clinical evidence of response to T-cell based immuno-oncology agents (e.g., non-small cell lung cancer \[NSCLC\], small cell lung cancer \[SCLC\], head and neck squamous cell cancer, hepatocellular carcinoma, gastric or gastroesophageal junction carcinoma, nasopharyngeal carcinoma, renal cell carcinoma, cervical cancer, triple-negative breast cancer, ovarian cancer (OC), endometrial carcinoma, esophageal cancer, melanoma, urothelial carcinoma or participant with confirmed microsatellite instability-high \[MSI-H\] or mismatch repair deficient \[dMMR\] solid tumor, etc.). Enrollment of tumor types beyond above situations required sponsor's approval. 4. Part E: Participants with histologically or cytologically confirmed epithelial OC (including fallopian or primary peritoneal cancer) previously treated with 1 to 3 lines of systemic anticancer treatment; must have been platinum resistant and checkpoint inhibitor (CPI) naïve. 5. Participants must have had measurable disease as assessed by RECIST v1.1. Key Exclusion Criteria: Parts A, B and C 1. History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (CAR-T) cell therapy. 2. For participants with DLBCL in Part A, classified as T-cell/histiocyte-rich large B-cell lymphoma, high-grade B-cell lymphoma with myelocytomatosis viral oncogene homolog and B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, Epstein-Barr virus positive DLBCL, and transformed DLBCL. Parts A, B, C, D and E 3. Prior exposure to PI3K inhibitor. For participants in Part B and Part C, prior exposure to BTK inhibitor and/or PI3K inhibitor. 4. Any approved anticancer therapy, including hormonal therapy, or any investigational agent or participation in another clinical study with therapeutic intent within 14 days before first dose. 5. Treatment with systemic immune-stimulatory agents (including, but not limited to, interferons and interleukin-2) within 2 weeks or 5 half-lives of the drug, whichever was later, before first dose. 6. Known human immunodeficiency virus (HIV) infection, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows: * HBsAg (+), or * HBcAb (+) and HBV DNA detected, or * Presence of HCV antibody. Participants with presence of HCV antibody were eligible if HCV ribonucleic acid (RNA) was undetectable NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma neoplasm ovarian cancer ovarian carcinoma

As listed by the trial registrant

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

Advanced solid tumor Chronic lymphocytic leukemia Diffuse large B-cell lymphoma Follicular lymphoma Mantle cell lymphoma Marginal zone lymphoma Small lymphocytic lymphoma

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, 2148, Australia

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120, Australia

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Jining No Peoples Hospital West Branch

    Jining, Shandong, 272000, China

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Perth Blood Institute

    West Perth, Western Australia, 6005, Australia

  • Pindara Private Hospital

    Benowa, Queensland, 4217, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009, China

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