Actively Recruiting
Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-05-08
480
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.
CONDITIONS
Official Title
Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma, metastatic or unresectable castration-resistant prostate cancer, locally advanced or metastatic urothelial carcinoma, or unresectable Stage III or IV melanoma
- Disease progression following prior specified therapies depending on tumor type
- At least one measurable tumor lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function
- Use of highly effective contraception during the study for participants of reproductive potential; negative pregnancy test and not breastfeeding for women of childbearing potential
- For castration-resistant prostate cancer, continuous luteinizing hormone-releasing hormone agonist therapy or bilateral orchiectomy, castrate testosterone level, and metastatic disease confirmed by imaging
- Voluntary participation with signed informed consent
You will not qualify if you...
- Recent major surgery, radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments prior to first study dose
- Unresolved toxicity from previous anti-tumor therapy above Grade 1 per CTCAE v5.0
- Active central nervous system metastases
- Clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention
- Uncontrolled hypertension or history of hypertensive crisis/encephalopathy
- Severe cardiovascular or cerebrovascular disease
- History of interstitial lung disease or pneumonitis requiring corticosteroids
- Severe bone injury from tumor metastasis
- Severe infection within 28 days before first dose
- Active tuberculosis, hepatitis B or C infection
- History of immunodeficiency or organ transplantation
- History of another primary malignancy within 5 years except those cured with low recurrence risk
- Known hypersensitivity to study drugs or components
- Any condition likely to cause early study discontinuation
- Prior treatments with certain antibody-drug conjugates depending on cohort
- Recent live or live-attenuated vaccinations or systemic immunosuppressant use
- Active autoimmune disease requiring systemic therapy within 2 years
- Drug-related adverse events leading to permanent discontinuation of prior anti-PD-(L)1 or bevacizumab therapies
- Specific bleeding risks, gastrointestinal issues, wound problems, or anticoagulation use for certain cohorts
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Y
Yuteng Shen, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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