New pill takes on advanced cancers in first human test
NCT ID NCT07629258
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This early-stage study tests a new tablet called GW01-200 in 100 people with advanced solid tumors or blood cancers that have stopped responding to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. Participants will take the pill by mouth and be closely monitored for side effects and any signs of cancer control.
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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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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: * Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available. * Have at least one measurable target lesion. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Minimum life expectancy ≥ 3 months. * Adequate organ and marrow function. Exclusion Criteria: * Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s). * History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease. * Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression. * Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus. * Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose. * Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors. * Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug. * Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis. * Known history of infection with human immunodeficiency virus (HIV). * Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy. * For female subjects: currently pregnant or lactating. * Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc. * Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator. * Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hebei Cancer Hospital of Chinese Academy of Medical Sciences
RECRUITINGLangfang, Heibei, 065000, China
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Peking University Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors