New hope for advanced cancer: experimental drug combo enters human trials
NCT ID NCT06474455
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called SHR-9839, given with other cancer treatments, for people with advanced solid tumors that have not responded to standard therapy. The goal is to see if the combination is safe and can shrink tumors. About 156 adults aged 18-75 with certain cancers, including squamous non-small cell lung cancer, may join.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 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 to 75 years
- 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. Aged 18-75 years old (inclusive), regardless of gender. 2. Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer. 3. At least one measurable tumor lesion according to RECIST v1.1. 4. ECOG performance score of 0-1. 5. Life expectancy ≥ 12 weeks. 6. Adequate bone marrow and organ function. 7. Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements. Exclusion Criteria: 1. Patients with active central nervous system ( CNS ) metastases. 2. Spinal cord compression not be cured by surgery or radiotherapy. 3. Subjects with uncontrollable tumor-related pain. 4. Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion. 5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug. 6. Received \> 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug. 7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug. 8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug. 9. History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function. 10. Serious cardiovascular and cerebrovascular diseases. 11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug. 12. History of immunodeficiency, including HIV test positive. 13. Active hepatitis B or hepatitis C infection. 14. History of severe allergic reactions to any component of any study drug to be accepted. 15. Known history of alcohol or drug dependence. 16. Mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Patients with any active, known or suspected autoimmune disease. 19. Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study. 20. Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.
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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
2 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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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, 450003, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310005, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug that targets two cancer drivers tested in first human study
- New drug takes aim at Hard-to-Treat squamous lung cancer
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors