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

NCT06888830 | Recruiting Phase 1

• 1 other identifier: JS212-001-I/II
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Tumours

Outcome Measures

Primary Outcomes (5)

• DLT

  Incidence and severity of DLT events

  Up to 1 years

• Incidence and severity of Adverse Events

  Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

  Up to 2 years

• MTD

  Maximum tolerated dose

  Up to 1 years

• RP2D

  Recommended phase II dose

  Up to 1 years

• ORR

  Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1

  Up to 2 years

Secondary Outcomes (6)

• DOR

  Up to 2 years

• DCR

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Pharmacokinetic (PK)

  About 6 months after first dosing

Other Outcomes (2)

• To explore the correlation between potential MARKERS and efficacy

  Up to 2 years

• To explore the correlation between serum β-Glucuronidase Concentrations and efficacy

  Up to 2 years

Study Arms (1)

JS212

EXPERIMENTAL

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

Drug: JS212 for Injection

Interventions

JS212 for Injection DRUG

JS212 for Injection is administered on the first day of the first cycle and every 3 weeks thereafter.

JS212

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Histologically or cytologically confirmed advanced malignant solid tumors;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival of ≥ 12 weeks;
• Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase);

You may not qualify if:

• 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;
• Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);
• Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
• 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;
• 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;
• 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；
• 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；

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Zhihao Jiang, Master

CONTACT

86-15350403639; zhihao_jiang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)