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Advanced Malignant Solid TumorsPhase 2NCT07480733

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

A Phase 2 study testing JS212 for Injection, JS213 for Injection and JS207 for Injection in people with Advanced Malignant Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
JS212 for Injection, JS213 for Injection and JS207 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
1 siteChina
Study dates
23 Apr 2026to 11 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.
  • Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/exclusion criteria.
  • 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.
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  • 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；
  • Subjects participating in Cohorts 2, 3, 4, and 5: Administration of any live or live-attenuated vaccine within 28 days prior to the first dose, or anticipated need for such vaccination during the study.Use of systemic corticosteroids or other immunosuppressive agents for ≥7 consecutive days within 14 days prior to the first dose.Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior anti-PD-(L)1 antibody therapy.
  • Subjects participating in Cohorts 4:Imaging in the screening period demonstrates tumor encasement of major blood vessels, significant necrosis, or cavitation that, in the investigator's opinion, may confer a bleeding risk. Clinically significant hemoptysis or tumor bleeding of any cause within 28 days prior to the first dose.Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to enrollment, or current high risk of hollow organ perforation/fistula formation as judged by the investigator.History of gastrointestinal bleeding within 6 months prior to enrollment, or documented gastrointestinal bleeding tendency.Severe, non-healing or dehiscent wound, active ulcer, or untreated fracture.Significant bleeding diathesis or severe coagulopathy.Use of antiplatelet therapy or therapeutic anticoagulation within 14 days prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior bevacizumab or similar agent therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuteng Shen, Project manager contact

8618612107811

yuteng_shen@junshipharma.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, Ph.D, 086 010-88196317, guoj307@126.com

    Jun Guo, Ph.D

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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

Being tested
JS212 for Injection, JS213 for Injection, JS207 for Injection, Toripalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS212 for InjectionDrug

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

  • JS213 for InjectionDrug

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

  • JS207 for InjectionDrug

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

  • ToripalimabDrug

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

Study groups in NCT07480733
Study groupRoleWhat they receive
Arm 1: JS212 MonotherapyExperimentalNot described
Receives: Drug: JS212 for Injection
Arm 2: JS213 MonotherapyExperimentalNot described
Receives: Drug: JS213 for Injection
Arm 3: JS212 in Combination with JS213ExperimentalNot described
Receives: Drug: JS212 for Injection; Drug: JS213 for Injection
Arm 4: JS212 in Combination with JS207ExperimentalNot described
Receives: Drug: JS212 for Injection; Drug: JS207 for Injection
Arm 5: JS212 in Combination with ToripalimabExperimentalNot described
Receives: Drug: JS212 for Injection; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

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

    Measured: up to 6 years

Secondary outcomes (7)

  1. PFS

    Progression-free survival (PFS), assessed by investigators (per RECIST v1.1)

    Measured: up to 6 years

  2. DoR

    Duration of response (DoR), assessed by investigators

    Measured: up to 6 years

  3. DCR

    Disease control rate (DCR), assessed by investigators

    Measured: up to 6 years

  4. OS

    overall survival (OS)

    Measured: up to 6 years

  5. Safety (AE)

    Incidence and severity of adverse events (AEs)

    Measured: up to 6 years

  6. Number of Participants With Abnormal Laboratory Values or clinical findings

    Abnormal laboratory or clinical findings

    Measured: up to 6 years

  7. dose-limiting toxicity（DLT）

    Incidence and severity of dose-limiting toxicity（DLT）

    Measured: up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start23 Apr 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion11 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07480733
Sponsor's protocol ID
JS212-004-II
Status last verified
May 2026
First submitted
13 Mar 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS212 for Injection, JS213 for Injection and JS207 for Injection in people with Advanced Malignant Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuteng Shen, Project manager (8618612107811, yuteng_shen@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07480733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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