MelanomaPhase 1NCT04773951
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors
A Phase 1 study testing JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection in people with Melanoma and Renal Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 11 sites in China.
Trial summary
An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma, Renal Carcinoma, Urothelial Carcinoma
- What is being tested?
- JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 11 sitesChina
- Study dates
- 12 Apr 2021to 18 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only the patients meeting the following criteria are eligible to participate in the study:
- Voluntarily signed written informed consent form;
- Age ≥18 and ≤70 years at the time of signing informed consent form, male or female;
- Life expectancy ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Patients with histologically or cytologically confirmed advanced solid tumors: patients with advanced solid tumors who have failure in standard of care, cannot tolerate standard of care, refuse and/or have no standard of care (melanoma, renal carcinoma and urothelial carcinoma);
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- At least one measurable lesion as target lesion (RECIST v1.1);
- Agree to provide tumor tissue specimen ( fresh biopsied sample before treatment should be provided as far as possible, the archived sample within two years is acceptable for the patients who cannot provide fresh biopsied sample before treatment);
- Adequate organ function as indicated by the laboratory results during the screening period;
- Use of effective contraceptive methods during the study for male subjects of reproduction ability or female subjects of childbearing potential, and continuation of contraception for 6 months after the end of treatment;
- Good compliance, cooperation with follow-up.
Who cannot join
- Patients will be excluded from the study when they have any of the following conditions:
- History of malignant tumors other than the disease investigated in the past 5 years, however, except for the malignant tumors that can be expected to be cured after treatment;
- Having received systematic antitumor therapy, or local antitumor therapy, or treatment with clinically investigational medication or device within 4 weeks prior to the first dose of study drug;
- Having received immunotherapy within 4 weeks prior to first dose of study drug;
- Previously treated with anti-BTLA or anti-HVEM antibody;
- Adverse reaction induced by previous therapy having not recovered to CTCAE (version 5.0) grade 1 or better;
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- Having previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Having central nervous system metastases and/or cancerous meningitis;
- Having or suspected to have active autoimmune disease;
- Having hepatitis and liver cirrhosis;
- Massive hydrothorax or ascites with clinical symptoms or requiring symptomatic treatment;
- Having severe cerebro- and cardiovascular diseases;
- Having pulmonary disease;
- Having active infection requiring systemic treatment;
- Positive result for human immunodeficiency virus (HIV) antibody;
- Active hepatitis B or C;
- Known active tuberculosis (TB);
- Use of systemic corticosteroids 14 days prior to the first dose of study drug;
- Use of broad-spectrum antibiotics that may affect the change of intestinal flora within 14 days prior to the first dose of study drug;
- Vaccination of live vaccine within 4 weeks prior to the first dose of study drug;
- Having received major surgery within 4 weeks prior to the first dose of study drug;
- History of anti-psychotics abuse and unable to abstain, or with a history of mental disorder;
- Pregnant or breast-feeding women;
- Known allergy to JS004 and its components;
- Other severe, acute or chronic medical conditions or mental diseases or laboratory abnormalities possibly increasing relevant risks in participation in the study or possibly interfering with the interpretation of study results as judged by investigators.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Beijing Cancer Hospital
Beijing
First Hospital of Jilin University
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Run Run Shaw Hospital affiliated to Zhejiang University Medical College
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Tumor Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Fudan University Shanghai Cancer Center
Shanghai
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Humanized Monoclonal Antibody Specific to B- and T- Lymphocyte Attenuator, BTLA (JS004) Injection in Patients With Advanced Solid Tumors
An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period.
- Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion.
- Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter.
- Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.
- Conditions
- Melanoma, Renal Carcinoma, Urothelial Carcinoma
- Being tested
- JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab InjectionBiological
Biological: JS004, Intravenous infusion; Toripalimab Injection, Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and extension group | Experimental | 1. JS004 dose escalation: 1mg/kg, IV Q3W; 3mg/kg, IV Q3W; 10mg/kg, IV Q3W;
2. JS004 dose extension: 3mg/kg, IV Q3W; 200mg, IV Q3W;
3. JS004+Toripalimab Injection dose escalation: JS004 100mg+Toripalimab Injection 240mg, IV Q3W; JS004 200mg+Toripalimab Injection 240mg, IV Q3W;
4. JS004+Toripalimab Injection dose extension: JS004 100mg+Toripalimab Injection 240mg, IV Q3W or JS004 200mg+Toripalimab Injection 240mg, IV Q3W，to be determined. Receives: Biological: JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of JS004 injection alone and in combination with Toripalimab in patients with advanced solid tumors.
Including incidence of dose limiting toxicity (DLT); incidence and severity of adverse event (AE), serious adverse event (SAE) and immune related adverse event (irAE); laboratory results with clinical significance and other tests with abnormal results.
Measured: 2 years
Determine the maximum tolerated dose (MTD)/recommended extended dose (RDE) of JS004 injection monotherapy and combination with Toripalimab in patients with advanced solid tumors.
The maximum tolerated dose (MTD) is defined as the maximum dose at which <1/3 subjects experience any DLTs and at least 6 evaluable subjects are required at each dose level.
Measured: 2 years
Secondary outcomes (9)
To preliminarily evaluate the efficacy of JS004 injection as a single drug and combined with Toripalimab.
Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS) in accordance with RECIST 1.1 and overall survival (OS).
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Drug concentration in individual subject at different time points after administration.
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Peak concentration (Cmax)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time to peak (Tmax)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Area under the serum concentration-time curve (AUC0-t and AUC0-∞)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Clearance (CL)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Volume of distribution under steady state (Vss)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Mean retention time (MRT)
Measured: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Elimination half-life (t1/2)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start12 Apr 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773951
- Sponsor's protocol ID
- HMO-JS004-I-CT01
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Humanized Monoclonal Antibody Specific to B- and T- Lymphocyte Attenuator, BTLA (JS004) Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04773951
- Acronym / sponsor ID
- HMO-JS004-I-CT01
- Conditions
- Melanoma, Renal Carcinoma, Urothelial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period.
- Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion.
- Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter.
- Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and extension group | Experimental | Biological: JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection1. JS004 dose escalation: 1mg/kg, IV Q3W; 3mg/kg, IV Q3W; 10mg/kg, IV Q3W; 2. JS004 dose extension: 3mg/kg, IV Q3W; 200mg, IV Q3W; 3. JS004+Toripalimab Injection dose escalation: JS004 100mg+Toripalimab Injection 240mg, IV Q3W; JS004 200mg+Toripalimab Injection 240mg, IV Q3W; 4. JS004+Toripalimab Injection dose extension: JS004 100mg+Toripalimab Injection 240mg, IV Q3W or JS004 200mg+Toripalimab Injection 240mg, IV Q3W，to be determined. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Only the patients meeting the following criteria are eligible to participate in the study:
- Voluntarily signed written informed consent form;
- Age ≥18 and ≤70 years at the time of signing informed consent form, male or female;
- Life expectancy ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
Key exclusion criteria (25 listed)
- History of malignant tumors other than the disease investigated in the past 5 years, however, except for the malignant tumors that can be expected to be cured after treatment;
- Having received systematic antitumor therapy, or local antitumor therapy, or treatment with clinically investigational medication or device within 4 weeks prior to the first dose of study drug;
- Having received immunotherapy within 4 weeks prior to first dose of study drug;
- Previously treated with anti-BTLA or anti-HVEM antibody;
- Adverse reaction induced by previous therapy having not recovered to CTCAE (version 5.0) grade 1 or better;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab InjectionBiological: JS004, Intravenous infusion; Toripalimab Injection, Intravenous infusion | Biological | Dose escalation and extension group |
Primary outcome
To evaluate the safety and tolerability of JS004 injection alone and in combination with Toripalimab in patients with advanced solid tumors.
Time frame: 2 years
Including incidence of dose limiting toxicity (DLT); incidence and severity of adverse event (AE), serious adverse event (SAE) and immune related adverse event (irAE); laboratory results with clinical significance and other tests with abnormal results.
Determine the maximum tolerated dose (MTD)/recommended extended dose (RDE) of JS004 injection monotherapy and combination with Toripalimab in patients with advanced solid tumors.
Time frame: 2 years
The maximum tolerated dose (MTD) is defined as the maximum dose at which <1/3 subjects experience any DLTs and at least 6 evaluable subjects are required at each dose level.
9 secondary outcomes
To preliminarily evaluate the efficacy of JS004 injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo principal investigator
Peking University Cancer Hospital & Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection in people with Melanoma and Renal Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 11 sites 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 11 inclusion and 25 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: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of JS004 injection alone and in combination with Toripalimab in patients with advanced solid tumors. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.