Can a new drug shrink Hard-to-Treat tumors?
NCT ID NCT05502393
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This early-stage trial is testing an experimental drug called JS107 in people with advanced or metastatic solid tumors that have not responded to standard treatments. The study aims to find the safest dose and see how well the body tolerates JS107 when given alone or combined with another immunotherapy drug, toripalimab. Some participants may also receive chemotherapy drugs oxaliplatin and capecitabine as part of the combination. The goal is to determine the recommended dose for future studies and to look for early signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JS107 (an experimental drug) given alone or with toripalimab, and in some cases with oxaliplatin and capecitabine
- What this could lead to
- If JS107 proves safe and shows signs of shrinking tumors, it could become a new treatment option for advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial focused on safety and dosing, so it is too soon to know if JS107 will work. Side effects may be significant, and the drug may not benefit all patients.
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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133 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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 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. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form; 2. Aged ≥18 years and ≤75 years when the subject signed the informed consent; 3. Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ; 4. Provide past tumor samples or fresh tumor tissue biopsy samples; 5. The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale; 6. The expected survival is ≥3 months; 7. There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria; 8. Any adverse events and/or complications resulting from prior treatment, including surgery or radiation therapy, that have been adequately resolved to level 0 or 1 (according to the NATIONAL Cancer Institute Standard for General Terminology of Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria; Any grade of hair loss/pigmentation and other long-term toxicity caused by treatment, except those that are irreversible and do not affect study dosing/compliance and patient safety at the discretion of the investigator; 9. Good organ function; 10. Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 6 months after the last dose. Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 6 months after the last dose. Exclusion Criteria: 1. Prior treatment with drugs or other therapies targeting CLDN18.2; 2. A history of severe allergic reactions to other monoclonal antibodies or to any component of JS107, or to other drugs or excipients involved in the trial protocol ; 3. Received radiotherapy (except palliative radiotherapy for symptom control), chemotherapy, targeted therapy, endocrine therapy and other antitumor therapies, or other investigational drugs within 4 weeks before the administration of the first dose; 4. Received any monoclonal antibody or antibody conjugate within 4 weeks prior to administration of the first study drug or within 5 half-lives (depend on whichever is shorter); 5. Persons who have an immunodeficient disease or the other chronic immunosuppressive therapy, or who have received systemic immunomodulatory drugs (including, but not limited to, interferon or IL-2) within 14 days before first dose or within the 5 half-life of the drug (depend on whichever is longer), or received systemic glucocorticoid therapy (10mg daily of prednisone or equivalent glucocorticoids) or other systemic immunosuppressive therapy within 14 days before first dose; 6. Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose; 7. Serious infection (CTCAE\> grade 2) occurred within 14 days before the first dose; 8. Patients with other malignant tumors except for the tumor treated in the study within 5 years prior to the administration of the first study drug (exceptions included: cured malignancies that had not recurred within 3 years prior to study enrollment; Completely resected basal and squamous cell skin cancers; Complete resection of any type of carcinoma in situ, etc.); 9. Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug; 10. Weight loss 10% within 2 months before drug administration, or other indicators of severe malnutrition, or body mass index (BMI)\<17.5 at the time of signing the informed consent. 11. The following conditions were present within 6 months prior to the first study dose: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure , hypertensive crisis, or hypertensive encephalopathy; patients with known hypertension, coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \<50% must be treated with optimal stabilization as determined by the treating physician medical plan; 12. Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment; 13. Poorly controlled pain related; 14. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be manifested by the onset of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth; 15. Active infection, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive); 16. History of autoimmune disease; 17. Idiopathic pulmonary fibrosis, drug-induced pneumonia, machine-induced pneumonia (bronchiolitis obliterans), radioactive pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function ; 18. Pregnant or lactating women; 19. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 20. Have serious psychological or mental abnormality, which affects the compliance of the subject to participate in this clinical study; 21. Participated in any other clinical trial within 28 days prior to the first administration of study drug; 22. Other conditions deemed inappropriate for study participation 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.
Contacts and locations
Locations
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Anyang Tumor Hospital
An'yang, Henan, 455100, China
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First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
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Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
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Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733000, China
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
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Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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Meizhou People's Hospital
Meizhou, Guangdong, 514000, China
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Suining Central Hospital
Suining, Sichuan, 629000, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266061, China
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The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
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The First Affiliated Hospital of Henan University of Science and Technology
Hangzhou, Zhejiang, 310009, China
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The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453003, China
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The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310003, China
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The First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011, China
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The People's Hospital of Chizhou
Chizhou, Anhui, 247099, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430010, China
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Wuhan University People's Hospital
Wuhan, Hebei, 430060, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
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