Experimental cancer drug trial halted early
NCT ID NCT06487858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new experimental drug called BGB-R046, given alone or with another drug (tislelizumab), in people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. The trial was terminated early, so results are limited.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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42 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Apr 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: * Participants able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection * Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement * ≥ 1 measurable lesion per RECIST v1.1 * Able to provide an archived tumor tissue sample * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Adequate organ function * Life expectancy \>12 weeks as determined by the investigator Exclusion Criteria: * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Active autoimmune diseases or history of autoimmune diseases that may relapse * Any malignancy ≤ 3 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) * History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases. * Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4, or other experimental drugs) * Uncontrolled diabetes \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drug(s). * Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s) * Immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
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Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
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Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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- Engineered immune cells target two markers on Hard-to-Treat tumors