JS212 for advanced solid tumors: early safety and initial efficacy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/II, open-label interventional study gives JS212 by injection to adults with advanced malignant solid tumors, using a dose-escalation stage followed by a dose-expansion stage. During dose escalation, small cohorts will receive increasing doses to define safety, tolerability, pharmacokinetics, and a recommended dose for expansion. The dose-expansion stage will treat a larger group at the selected dose to look for initial anti-tumor activity by RECIST v1.1 while continuing safety monitoring. Key eligibility includes age 18–75 years, ECOG performance status 0–1, expected survival ≥12 weeks, and exclusions for active untreated central nervous system metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form;
2. Histologically or cytologically confirmed advanced malignant solid tumors;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
4. Expected survival of ≥ 12 weeks;
5. Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase);

Exclusion Criteria:

1. Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;
2. Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);
3. Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
4. Presence of a history of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD/non-infectious pneumonia;
5. Presence of clinically significant lung-specific co-morbidities including, but not limited to, any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, etc., diagnosed within 3 months prior to the first study dose) and any autoimmune, connective tissue, or inflammatory disease with pulmonary involvement (e.g., rheumatoid arthritis, Scheugelin's syndrome, sarcoidosis, etc.) and prior total pneumonectomy;
6. Presence of a history of immunodeficiency, including a positive test for Human Immunodeficiency Virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation；
7. the presence of other factors that may cause them to be forced to terminate the study midway, such as serious physical or mental illness or abnormal laboratory tests, which may increase the risk of participation in the study, affect treatment compliance, or interfere with the results of the study, and which, in the judgment of the investigator, make the subject unsuitable for participation in this study；

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhihao Jiang, Master
• Email: zhihao_jiang@junshipharma.com
• Phone: 86-15350403639

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners

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• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

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• JS212 plus JS111 in EGFR-mutant NSCLC: a Phase II study

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• JS212 combination treatments for metastatic colorectal cancer.

  This Phase 2 trial will test whether the experimental drug JS212, given with standard chemotherapy (capecitabine with or without bevacizumab or XELOX) and sometimes the immune drug JS207, is safe and active in adults with metastatic colorectal cancer who have not had prior systemic therapy for advanced disease.

  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07503756

• JS212 plus JS001 and 5‑FU for advanced esophageal squamous cell carcinoma

  This will test whether combining JS212 with JS001 and 5‑FU helps people with advanced esophageal squamous cell carcinoma who have not had prior systemic anti‑cancer therapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.