JS212 for advanced solid tumors: early safety and initial efficacy

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour

This trial will test whether the investigational injection JS212 is safe, how the body processes it, and whether it shows early signs of benefit in adults with advanced solid tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 374 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06888830 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed advanced malignant solid tumors, ECOG 0–1, expected survival of at least 12 weeks, and willing to receive intravenous injections and follow-up at the study site are the intended candidates.

Not a fit: Patients with active, untreated central nervous system metastases, poor performance status (ECOG >1), or who cannot attend the Shanghai study site are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, JS212 could provide a new treatment option that stabilizes or shrinks advanced solid tumors for patients with limited alternatives.

How similar studies have performed: Dose-escalation followed by expansion is a common early-phase oncology approach and some agents in this design have produced promising initial responses, but JS212 is investigational and no published efficacy results for this agent are currently available.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhihao Jiang, Master

Conditions Advanced Malignant Solid Tumours