New drug combo aims to fight Hard-to-Treat cancers
NCT ID NCT07298772
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a new drug called SHR-4375 combined with other anti-cancer treatments in people with advanced solid tumors that no longer respond to standard care. The trial will enroll about 198 participants to check safety, find the best dose, and see if tumors shrink. It is an early-stage study, so results are uncertain but could lead to better options for patients with limited choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-4375 injection combined with other anti-cancer drugs
- What this could lead to
- If successful, this could point toward a new combination treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial with only 198 participants, so the drug may not prove effective or safe enough for wider use. Side effects and limited tumor response are possible.
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 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2028
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. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 12 weeks. 5. Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate bone marrow and organ function. 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. Exclusion Criteria: 1. There are components of neuroendocrine carcinoma or sarcoma in the histopathological type. 2. Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration. 3. Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period. 4. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration. 5. Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors. 6. Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study. 7. Suffering from other active malignant tumors within 3 years or at the same time. 8. Symptomatic or active central nervous system tumor metastasis. 9. Accompanied by uncontrolled tumor related pain. 10. Subjects who have experienced severe infections within 30 days prior to their first medication use. 11. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past. 12. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1. 13. Active hepatitis B or active hepatitis C. 14. Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication. 15. Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion. 16. Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention. 17. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
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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
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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
- New antibody drug conjugate tested against advanced cancers