Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal CancerPhase 1NCT05427396

A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors

A Phase 1 study testing JS004 and Toripalimab Injection in people with Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open-label phase I study to evaluate the safety, tolerability, and initial efficacy of JS004 injection combined with Toripalimab Injection in patients with advanced solid tumors who have failed standard therapy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
What is being tested?: JS004 and Toripalimab Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 2 sitesChina
Study dates: 28 Jul 2022to 15 Jan 2024
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

Sign the informed consent form voluntarily;
Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
Expected survival ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Patients with advanced solid tumors confirmed histologically or cytologically
At least one measurable lesion as a target lesion (RECIST v1.1 criteria);

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Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible;
The patient has good organ function as indicated by screening laboratory results
Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
Good compliance and cooperated with the follow-up.

Who cannot join

Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
Central nervous system metastases and/or cancerous meningitis
Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis

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A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure>140mmHg and/or diastolic pressure> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
A positive result for human immunodeficiency virus (HIV) antibody test;
Known active tuberculosis (TB).
Live vaccine was administered within 4 weeks prior to 1st administration
Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
Pregnant or lactating woman;
Known to be allergic to JS004 or toripalimab and its components;
Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Chinese PLA General Hospital
Beijing, Beijing Municipality
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability,of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors

Conditions: Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
Being tested: JS004, Toripalimab Injection
Medical subject headings: Liver Neoplasms, Esophageal Squamous Cell Carcinoma, Uterine Cervical Neoplasms

What participants receive

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

JS004Drug
Usage and dosage: Inject 200mg once every 3 weeks
Toripalimab InjectionDrug
Usage and dosage: Inject 240mg once every 3 weeks

Study groups in NCT05427396
Study group	Role	What they receive
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks	Other	Not described Receives: Drug: JS004; Drug: Toripalimab Injection

What is being measured

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

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
Measured: 2 years

Secondary outcomes (7)

OS
Duration of Response
Measured: 2 years
DOR
Duration of Response
Measured: 2 years
DCR
Disease Control Rate
Measured: 2 years
PFS
Progression-free survival
Measured: 2 years
ORR
Overall Response Rate
Measured: 2 years
TTR
Time to remission
Measured: 2 years
TTP
time to progression
Measured: 2 years

Timeline

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

28 Jul 202215 Jan 2024

First posted22 Jun 2022
Study start28 Jul 2022
Primary completion15 Jan 2024
Study completion15 Jan 2024

Why it stopped: The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal CancerStudies 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
Model description: Single Group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05427396
Sponsor's protocol ID: JS004-005-I
Status last verified: Nov 2025
First submitted: 5 Jun 2022
Last updated: 3 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability,of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05427396
Acronym / sponsor ID: JS004-005-I
Conditions: Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
Enrolment: 31 participants (actual)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Collaborators: Sponsor GmbH
Study start: 28 Jul 2022 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 15 Jan 2024 (actual)
First posted: 22 Jun 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group

Arm	Type	Receives
JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks	Other	Drug: JS004, Drug: Toripalimab Injection

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Sign the informed consent form voluntarily;
Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;
Expected survival ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Patients with advanced solid tumors confirmed histologically or cytologically

Key exclusion criteria (17 listed)

Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);
patients received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
Central nervous system metastases and/or cancerous meningitis

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
JS004Usage and dosage: Inject 200mg once every 3 weeks	Drug	JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks
Toripalimab InjectionUsage and dosage: Inject 240mg once every 3 weeks	Drug	JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks

Primary outcome

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Time frame: 2 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests

7 secondary outcomes

OS
Time frame: 2 years
DOR
Time frame: 2 years
DCR
Time frame: 2 years
PFS
Time frame: 2 years
ORR
Time frame: 2 years
TTR
Time frame: 2 years
TTP
Time frame: 2 years

Results and safety

The study was stopped early (reason given: The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 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: stopped early, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed (time frame: 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 NCT05427396.

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 3 Dec 2025.