New combo therapy tested for advanced cancers
NCT ID NCT05427396
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug (JS004) combined with another immunotherapy (Toripalimab) in 31 people with advanced solid tumors like liver, esophageal, stomach, cervical, or colorectal cancer. The goal was to check safety and see if the combination could help control the disease. The study was stopped early, so results are limited.
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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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31 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 70 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. Sign the informed consent form voluntarily; 2. Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent; 3. Expected survival ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Patients with advanced solid tumors confirmed histologically or cytologically 6. At least one measurable lesion as a target lesion (RECIST v1.1 criteria); 7. Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible; 8. The patient has good organ function as indicated by screening laboratory results 9. Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment; 10. Good compliance and cooperated with the follow-up. Exclusion Criteria: 1. Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent); 2. patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration 3. Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration 4. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past; 5. Central nervous system metastases and/or cancerous meningitis 6. Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis 7. A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment; 8. Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure\>140mmHg and/or diastolic pressure\> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)\<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication 9. Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm; 10. A positive result for human immunodeficiency virus (HIV) antibody test; 11. Known active tuberculosis (TB). 12. Live vaccine was administered within 4 weeks prior to 1st administration 13. Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration 14. Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders; 15. Pregnant or lactating woman; 16. Known to be allergic to JS004 or toripalimab and its components; 17. Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.
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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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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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