Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors

NCT07480733 | Recruiting Phase 2

• 1 other identifier: JS212-004-II
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate(ORR), assessed by investigator ( per RECIST v1.1).

  up to 6 years

Secondary Outcomes (7)

• PFS

  up to 6 years

• DoR

  up to 6 years

• DCR

  up to 6 years

• OS

  up to 6 years

• Safety (AE)

  up to 6 years

Study Arms (5)

Arm 1: JS212 Monotherapy

EXPERIMENTAL

Drug: JS212 for Injection

Arm 2: JS213 Monotherapy

EXPERIMENTAL

Drug: JS213 for Injection

Arm 3: JS212 in Combination with JS213

EXPERIMENTAL

Drug: JS212 for Injection; Drug: JS213 for Injection

Arm 4: JS212 in Combination with JS207

EXPERIMENTAL

Drug: JS212 for Injection; Drug: JS207 for Injection

Arm 5: JS212 in Combination with Toripalimab

EXPERIMENTAL

Drug: JS212 for Injection; Drug: Toripalimab

Interventions

JS212 for Injection DRUG

administered by intravenous infusion on Day 1 of each 21-day cycle.

Arm 1: JS212 Monotherapy; Arm 3: JS212 in Combination with JS213; Arm 4: JS212 in Combination with JS207; Arm 5: JS212 in Combination with Toripalimab

JS213 for Injection DRUG

administered by intravenous infusion on Day 1 of each 21-day cycle.

Arm 2: JS213 Monotherapy; Arm 3: JS212 in Combination with JS213

JS207 for Injection DRUG

administered by intravenous infusion on Day 1 of each 21-day cycle.

Arm 4: JS212 in Combination with JS207

Toripalimab DRUG

administered by intravenous infusion on Day 1 of each 21-day cycle.

Arm 5: JS212 in Combination with Toripalimab

Eligibility Criteria

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

You may qualify if:

• Age 18 to 75 years, male or female.
• 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.
• 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 or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and/or PD-(L)1 inhibitor therapy.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Adequate organ function.
• 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.
• 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.
• Subjects voluntarily participate in the study and have signed the informed consent form.

You may not qualify if:

• Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.
• Presence of active central nervous system (CNS) metastases.
• Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.
• Uncontrolled hypertension despite medical therapy, or history of hypertensive crisis or hypertensive encephalopathy.
• Severe cardiovascular or cerebrovascular disease.
• History of interstitial lung disease (ILD)/non-infectious pneumonitis requiring corticosteroid therapy.
• Severe bone injury due to tumor bone metastasis as judged by the investigator.
• Severe infection (CTCAE v6.0 \> Grade 2) within 28 days prior to the first study dose.
• Active tuberculosis, hepatitis B, or hepatitis C infection.
• History of immunodeficiency, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• History of another primary malignancy, except those with curative treatment and no known active disease for \>5 years and low potential risk of recurrence.
• Known hypersensitivity or severe allergic reaction to the study treatment, any of its components, or excipients.
• Presence of any other condition that may result in premature discontinuation from the study.
• Diagnosis of any other malignancy within 5 years.
• Subjects participating in Cohorts 1, 3, 4, and 5:Prior treatment with an ADC targeting EGFR and/or HER3, or prior treatment with an ADC utilizing a topoisomerase I inhibitor as the payload；

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Injections; toripalimab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yuteng Shen, Project manager

CONTACT

8618612107811; yuteng_shen@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 11, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)