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

Phase 1

Not yet recruiting

• Conditions: Advanced Malignant Solid Tumours
• Interventions: Drug: JS212 for Injection

• Registration Number: NCT06888830
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-30
• Primary Completion: 2026-07-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 374

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JS212	JS212 for Injection	If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.

Primary Outcome Measures

Name	Time	Method
DLT	Up to 1 years	Incidence and severity of DLT events
Incidence and severity of Adverse Events	Up to 2 years	Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
MTD	Up to 1 years	Maximum tolerated dose
RP2D	Up to 1 years	Recommended phase II dose
ORR	Up to 2 years	Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
DOR	Up to 2 years	Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1
DCR	Up to 2 years	Investigator-assessed Duration of objective Response (DCR) according to RECIST v1.1
Progression-Free Survival (PFS)	Up to 2 years	Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1
Overall Survival (OS)	Up to 2 years	Overall Survival (OS)
Pharmacokinetic (PK)	About 6 months after first dosing	Patient blood concentrations and pharmacokinetic parameters after drug administration
Immunogenicity	About 6 months after first dosing	Incidence of antidrug antibodies (ADA)

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China