New drug targets Hard-to-Treat cancers with missing gene
NCT ID NCT07583771
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug, CS08399, in people with advanced solid tumors or lymphoma that have a specific gene deletion (MTAP). The main goal is to find a safe dose and understand how the drug works in the body. About 186 participants will take part, and researchers will also look for signs that the drug shrinks tumors or slows disease.
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 186 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
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: 1. Understand and sign the informed consent form voluntarily. 2. ≥18 years old when signing the informed consent, regardless of sex. 3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed/refractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing. 4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria. 5. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1. 6. Adequate organ function. 7. Life expectancy ≥3 months. 8. Able to swallow and retain oral study medication. Exclusion Criteria: 1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter). 2. Previously received MAT2A or PRMT5 inhibitors. 3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures. 4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1. 5. History of other primary malignancies within 5 years prior to the first dose. 6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening. 7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement. 8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening. 9. Active infection requiring systemic anti-infective treatment at screening. 10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms. 11. Uncontrolled or significant cardiovascular disease. 12. Poorly controlled diabetes. 13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption. 14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose. 15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening. 16. Serious thromboembolic events within 6 months prior to the first dose. 17. Active tuberculosis at screening. 18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening. 19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases. 20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation. 21. History of alcohol abuse or drug abuse. 22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial. 23. Pregnant or breastfeeding women. 24. Other conditions deemed unsuitable for participation in this trial by the 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.
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
1 site. 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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Fudan University Shanghai Cancer Center
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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- Can PET scan signals predict who beats lung cancer with immunotherapy?