Experimental drug BAT8010 tested in patients with advanced cancers
NCT ID NCT05848466
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested an experimental drug called BAT8010 in 23 people with advanced or metastatic solid tumors who had no other standard treatment options. The main goals were to check safety, find the best dose, and see if the drug shows any sign of shrinking tumors. Participants received one of eight different doses every three weeks. The study is now complete, but results are not yet available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAT8010 (an experimental drug given by IV)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 23 participants, so it is too small to prove effectiveness. The drug may cause serious side effects or fail to 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
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23 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Jun 2025
- 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
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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 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: * Voluntary signing of informed consent. * The expected survival period is more than 3 months base on the evaluation of the investigator. * Eastern Cooperative Oncology Group (ECOG) should be 0-1. * Patients who fail to standard treatment or have no standard treatment or are not suitable for standard treatment at this stage, and who have Human epidermal growth factor receptor-2 (HER2) expression (including Immunohistochemistry (IHC)3+, IHC2+/fluorescence in situ hybridization (FISH)+and IHC2+/FISH - patients) confirmed by histopathology and cytopathology, the dose escalation stage includes but is not limited to breast cancer, gastric cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial cancer, etc., and the expansion stage only includes breast cancer. * An evaluable tumor focus was necessary in the dose escalation stage, and at least one measurable tumor focus in the dose expanding stage (according to RECIST 1.1 standard). * Enough organs, bone marrow reserve function and heart function. * Must agree to take effective contraceptive methods to prevent pregnancy. Exclusion Criteria: * Previously received HER2 targeted drug therapy such as trastuzumab or pertuzumab, Trastuzumab Emtansine or Enhertu, and the treatment of topoisomerase I inhibitors (such as irinotecan), there were adverse event (AE) equal to or pass 3 levels that were determined to be treatment-related or drug related * Before the first administration of the investigational drug, the AE (CTCAE5.0) caused by previous anti-tumor treatment was still higher than grade 1 * Primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or previous history of epilepsy. Patients with asymptomatic or symptomatic central nervous system metastasis who have achieved clinical control but are judged stable by the investigator can be included. * Major surgery has been performed within 28 days before the first use of the study drug, or if it has been more than 21 days after surgery, but the postoperative complications are still continuing. * Subjects who had severe infection within 4 weeks before the first administration, or had any symptoms and signs of active infection within 2 weeks before the first administration. * Untreated or under treatment tuberculosis subjects, with a history of immune deficiency, or other immune deficiency diseases, or with a history of organ transplantation. * Active hepatitis B virus infected, hepatitis C virus infected, Treponema pallidum antibody positive and Rapid plasma reagin ring card test (RPR) positive. * Patients with symptomatic congestive heart failure (New York Heart Association (NYHA) grade II to IV) or serious arrhythmia requiring treatment (QTc prolongation of 12-lead electrocardiogram (ECG) 450 ms \[male\], 470 ms \[female\]), and patients with myocardial infarction and unstable angina pectoris in the past 6 months. Except for atrial fibrillation or paroxysmal supraventricular tachycardia * Patients who have a history of non-infectious pneumonia requiring glucocorticoid treatment or who currently have interstitial lung disease. * There are any other serious potential diseases. * Previous anti-tumor therapy (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) is less than 28 days from the first study administration. * Therapeutic radiopharmaceuticals must be discontinued 8 weeks before the first study administration. * Known allergy or intolerance to the study drug or its excipients. * Pregnant or lactating women. * The study participants who were considered unsuitable for the study by investigator.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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