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Unresectable or Advanced Clear Cell Renal Cell Carcinoma That Has Progressed After Previous ImmunotherapyPhase 2NCT06730932

A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy

A Phase 2 study testing JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously) in people with Unresectable or Advanced Clear Cell Renal Cell Carcinoma That Has Progressed After Previous Immunotherapy, run by RenJi Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
30 Oct 2025to 30 Dec 2027
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

  • Have fully understood and voluntarily signed the Informed Consent Form (ICF);
  • 18-75 years old (at the time of signing the informed consent form); No gender restrictions; ECOG PS score: 0-1 points;
  • Renal cell carcinoma with clear cell components confirmed by histology or cell pathology, including metastatic renal cell carcinoma mainly composed of clear cell components;
  • Previous treatment history of the subject: Patients who have received 1-2 systemic treatments containing immunotherapy and have experienced disease progression or intolerance;
  • Confirm the presence of at least one measurable lesion according to RECIST 1.1 criteria;
  • Agree to provide sufficient previously stored tumor tissue specimens or agree to undergo biopsy
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  • Collect tumor tissue for PD-L1, CD8 expression level determination, and MSI, TMB, KRAS, BRAF, PIK3CA, NRAS, PTEN, EGFR, HER2, HRAS, KIT, MET, ROS1, POLE, POLD1, TP53 gene mutation detection; 7. The main organ functions well and meets the following standards:
  • Blood routine examination standards (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 2 weeks before the first trial medication):
  • Hemoglobin (HGB) ≥ 90g/L;
  • Absolute neutrophil count (NEUT) ≥ 1.5 × 109/L;
  • Platelet count (PLT) ≥ 100 × 109/L.
  • Biochemical tests must meet the following standards:
  • Serum total bilirubin (TBIL) ≤ 1.5 × ULN or direct bilirubin ≤ 1.0 × ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If accompanied by liver metastasis, ALT and AST should be ≤ 5 × ULN;
  • Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60ml/min
  • Coagulation function test:
  • Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN, unless the subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at screening;
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • Endocrine function: Normal thyroid stimulating hormone (TSH), or abnormal TSH but normal FT3 and FT4; 8. Willing and able to comply with the research plan\'s visits, treatment laboratory tests, sample collection, and other procedures; 9. Female patients with fertility must voluntarily adopt efficient contraceptive measures (such as oral contraception, injection contraception, or implanted barrier contraception, spermicides and condoms, or intrauterine devices) for at least 120 days from the last dose during the study period, and have negative urine or serum pregnancy test results ≤ 7 days before enrollment; 10. Male patients who have not been sterilized must voluntarily adopt effective contraceptive measures for at least 120 days from the last dose during the study period.

Who cannot join

  • Participants who meet any of the following criteria will not be allowed to enter this study:
  • History of malignant tumors other than the research disease within the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma, or radical surgery for ductal carcinoma in situ);
  • Four weeks before the first study medication, receive systemic treatment with other anti-tumor drugs (if it has a half-life of five, it can be included in the group), or receive local anti-tumor treatment, or receive clinical investigational drug or device treatment;
  • Received immunotherapy within 4 weeks prior to the first study medication;
  • Have undergone major surgery (as determined by the investigator) or are in the recovery period within 4 weeks prior to the first trial administration;
  • Patients who have previously received treatment with anti BTLA or anti HVEM antibodies;
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  • Have a history of severe drug allergies, including but not limited to antibody drugs;
  • Patients with contraindications for immunotherapy restart: a) grade 2-4 immune myocarditis; b) Severe grade 4 proteinuria; c) Severe or life-threatening grade 4 immune hepatitis; d) Severe grade 3-4 immune pneumonia; e) Severe inflammatory arthritis that significantly affects daily life or quality of life; f) Severe neurological toxicity: grade 2-4 myasthenia gravis; Any level of Guillain Barr é syndrome (GBS) or transverse myelitis; Grade 2-4 encephalitis; g) Severe or life-threatening grade 3-4 pancreatitis; h) Serious or life-threatening bullous diseases (grades 3-4); i) Severe grade 3-4 uveitis or episcleritis;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, or requiring long-term treatment with corticosteroids;
  • Only hypothyroidism, suprarenal or pituitary dysfunction that can be controlled by hormone replacement therapy, type I diabetes, psoriasis or vitiligo that does not need systematic treatment can participate in this study;
  • The toxicity has not improved after previous anti-tumor treatment, that is, it has regressed to baseline, NCI-CTCAE 5.0 grade 0-1 (except for hair loss), or the level specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that is reasonably expected not to be exacerbated by the investigational drug can be included in this study;
  • Suffering from central nervous system metastasis and/or malignant meningitis. Subjects who have received treatment for brain metastases may be considered for participation in this study, provided that their condition has been stable for at least 3 months, no disease progression has been confirmed by imaging examinations within 4 weeks prior to the first administration of the study, all neurological symptoms have returned to baseline levels, there is no evidence of new or expanded brain metastases, and radiation, surgery, or steroid therapy has been discontinued at least 28 days prior to the first administration of the study treatment;
  • The known history of liver diseases with clinical significance, including those with active viral hepatitis (when hepatitis B virus surface antigen (HBsAg) and or hepatitis B virus core antibody (HbcAb) are positive, hepatitis B B virus (HBV) DNA\>10000 copies/mL or\>2000 IU/mL; Hepatitis C virus (HCV) antibody positive and HCV RNA positive, or other active hepatitis, clinically significant moderate to severe cirrhosis;
  • Patients with uncontrolled third interstitial fluid accumulation that requires repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (patients who do not require drainage or have no significant increase in fluid accumulation after stopping drainage for 3 days can be enrolled);
  • Corticosteroid drugs (prednisone\>10mg/day or equivalent dose) or other immunosuppressive drugs received systemically within 14 days prior to the first study medication;
  • Patients with any severe and/or uncontrolled illnesses, including:
  • Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg);
  • Unstable angina or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months prior to study medication;
  • Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms), and grade ≥ 2 congestive heart failure (NYHA classification); Grade II or above heart conduction block; Left ventricular ejection fraction (LVEF)\<50%;
  • Poor control of diabetes (FBG\>10 mmol/L);
  • Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0g;
  • Active or uncontrolled severe infections;
  • Suffering from or suspected to have active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc;
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • History of receiving attenuated live vaccines within 4 weeks prior to the first study medication or expected to receive attenuated live vaccines during the study period;
  • Individuals with a history of substance abuse and inability to quit, or those with a history of mental disorders;
  • Pregnant or lactating women;
  • Based on the researcher\'s assessment, there may be other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the interpretation of the research results.

Trial locations and contacts

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

Jiwei Huang, Dr contact

021-68383544

jiweihuang@outlook.com

China1 site

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    jiwei jiwei Huang, PhD., 8621-68383544, jiweihuang@outlook.com

Other trials in China

About this study

This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive JS004（B/T lymphocyte attenuator factor monoclonal antibody） plus Toripalimab until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators(continuous treatment for up to 2 years).

Being tested
JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously)
Keywords
JS004, Toripalimab, ccRCC, immunotherapy

What participants receive

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

  • JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously)Drug

    Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection 200mg via IV infusion once every 3 weeks

    Toripalimab 240mg via IV infusion once every 3 weeks

    JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol

Study groups in NCT06730932
Study groupRoleWhat they receive
JS004 combine with ToripalimabExperimentalNot described
Receives: Drug: JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously)

What is being measured

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

  1. ORR per RECIST v1.1 as assessed by investigators

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    Disease control rate (DCR) assessed according to RECIST v1.1

    Measured: Up to 2 years

  3. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment until death due to any cause.

    Measured: Up to 2 years

Timeline

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

  1. First posted12 Dec 2024
  2. Study start30 Oct 2025 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Dec 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730932
Sponsor's protocol ID
RCC-IIT-JS004-S01
Status last verified
Sep 2025
First submitted
8 Dec 2024
Last updated
29 Sep 2025
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 JS004（BTLA monoclonal antibody，intravenously）,Toripalimab（ anti-PD-1specific antibody，intravenously) in people with Unresectable or Advanced Clear Cell Renal Cell Carcinoma That Has Progressed After Previous Immunotherapy, run by RenJi Hospital 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 19 inclusion and 29 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: opening soon, as of the sponsor's last update on 29 Sep 2025. 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 Jiwei Huang, Dr (021-68383544, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR per RECIST v1.1 as assessed by investigators (time frame: Up to 2 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 NCT06730932.

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 Sep 2025.

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