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A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

NCT07480733•Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This study is a Phase II clinical trial designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of JS212 and JS213 as monotherapy and in combination therapy in patients with advanced malignant solid tumors. This study plans to conduct 5 treatment cohorts: Cohort 1: JS212 Cohort 2: JS213 Cohort 3: JS212 + JS213 Cohort 4: JS212 + JS207 Cohort 5: JS212 + Toripalimab

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 75 years, male or female.
•2. Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma.
•3. For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy; for melanoma: disease progression following prior chemotherapy and PD-(L)1 inhibitor therapy.
•4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
•5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
•6. Life expectancy ≥ 12 weeks.
•7. Adequate organ function.
•8. Male and female subjects of reproductive potential must agree to use highly effective contraception during the study and avoid conception; women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding.
•9. CRPC subjects must be on continuous luteinizing hormone-releasing hormone agonist (LHRHa) therapy or have undergone bilateral orchiectomy; subjects without bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study; castrate levels of testosterone at screening; metastatic disease confirmed by CT/MRI or radionuclide bone scan.
•10. Subjects voluntarily participate in the study and have signed the informed consent form.

Exclusion Criteria

•1. Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.
•3. Presence of active central nervous system (CNS) metastases.
•4. Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.
•5. Uncontrolled hypertension despite medical therapy, or history of hypertensive crisis or hypertensive encephalopathy.
•6. Severe cardiovascular or cerebrovascular disease.
•7. History of interstitial lung disease (ILD)/non-infectious pneumonitis requiring corticosteroid therapy.
•8. Severe bone injury due to tumor bone metastasis as judged by the investigator.
•9. Severe infection (CTCAE v5.0 \> Grade 2) within 28 days prior to the first study dose.
•10. Active tuberculosis, hepatitis B, or hepatitis C infection.
•11. History of immunodeficiency, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
+7 more criteria

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 2, 2026

Primary Completion Date

November 30, 2027

Completion Date

November 11, 2028

Last Updated

March 18, 2026

Enrollment

480

ESTIMATED participants

Conditions

Advanced Malignant Solid Tumors

Interventions

JS212 for Injection

DRUG

JS213 for Injection

DRUG

JS207 for Injection

DRUG

Toripalimab

DRUG

Contacts

Yuteng Shen, Project manager

CONTACT

8618612107811 yuteng_shen@junshipharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

Inclusion Criteria

Exclusion Criteria

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors

Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor

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