Advanced TumorsPhase 1NCT05061628
The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor
A Phase 1 study testing JS006 as Monotherapy and JS006 in combination with Toripalimab in people with Advanced Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies or who have no standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- JS006 as Monotherapy and JS006 in combination with Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 23 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding and signature of the informed consent form voluntarily;
- Age 18 - 75 years (inclusive), male or female;
- Pathologically confirmed advanced malignancy who have failed standard treatment or with no standard treatment available;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Expected survival ≥ 12 weeks;
- Having at least one measurable lesion that meets RECIST v1.1 criteria or Lugano 2014 criteria;
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- The function of vital organs meets the following requirements (no blood transfusion or blood products and no hematopoietic stimulating factors and other drugs to correct blood cell counts within 14 days before the examination):
- 7-1.Absolute neutrophil count (ANC) ≥1.5 × 109/L; 7-2. Platelet count (PLT) ≥ 90 × 109/L; 7-3.Hemoglobin (Hb) ≥ 90 g/L; 7-4.Total bilirubin (TBIL) ≤ 1.5 × ULN, or for patients with liver metastases or Gilbert syndrome, TBIL ≤ 3 × ULN; 7-5.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or for patients with liver metastases, ALT and AST ≤ 5 × ULN; 7-6.Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min; 7-7.For patients not receiving anticoagulant therapy, international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN; For patients receiving anticoagulation therapy (such as low molecular weight heparin or warfarin) require a stable dose of anticoagulant drugs for at least 4 weeks without dose adjustment; 7-8.QTc interval calculated according to Fridericia's criteria ≤ 450 ms for males and ≤ 470 ms for females;
- Female patients of childbearing potential and male patients whose partners are women of childbearing potential are willing to use effective contraceptive measures during the study treatment and for 6 months after the last dose; Female patients of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must be non-lactating. The childbearing potential is defined as a woman who has not undergone surgical sterilization, hysterectomy and/or bilateral oophorectomy or who is not postmenopausal (amenorrhea ≤ 12 months).
Who cannot join
- Patients who met any of the following criteria will be excluded from the study:
- Known allergic to toripalimab or ingredients of JS006;
- Have received anti-TIGIT or related targets CD155, CD112 or CD113 antibody treatment in the past;
- Participation in other clinical studies within 4 weeks before the first dose, except for an observational (non-interventional) clinical study or follow-up period of an interventional study;
- Major surgery (as judged by the investigator) within 4 weeks before the first dose or in the recovery period of surgery;
- Received systemic anti-tumor therapy within 4 weeks before the first dose, such as chemotherapy (or within 6 weeks for the last chemotherapy with nitrosourea or mitomycin), radiotherapy, targeted therapy, immunotherapy or biological therapy. Received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose of JS006. Hormone therapy, such as insulin for diabetes, hormone replacement therapy, etc., is acceptable for non-tumor-related diseases. Local palliative treatment (such as local surgery or radiotherapy) for isolated lesions can be accepted without affecting the efficacy evaluation;
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- Patients who discontinued prior immunotherapy due to immune-related adverse reactions;
- Received immunosuppressive medications within 4 weeks before the first dose, except corticosteroid nasal spray, inhalers, or systemic prednisone ≤ 10 mg/day or equivalent;
- Received allogeneic bone marrow transplantation or solid organ transplantation in the past;
- Patients who received live attenuated vaccination within 30 days before the first dose;
- Patients with two or more malignancies within 5 years before the first dose, except for early malignancy (carcinoma in situ or stage I tumors) that have been cured, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer;
- Presence of central nervous system (CNS) metastases that are symptomatic, untreated, or require continued treatment (including corticosteroids and antiepileptic drugs). Patients who previously received treatment but were clinically stable for at least 4 weeks before enrollment can be enrolled, excluding patients with evidence of new or expanded metastasis and discontinued steroid therapy;
- The toxicity has not resolved after prior anti-tumor therapy, which means do not recover to baseline, NCI-CTCAE 5.0 Grade 0 to 1 (except alopecia, pigmentation) or the level specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that is reasonably not expected to be aggravated by the study drug can be enrolled after consultation with the medical monitor;
- Patients with autoimmune disorder within the previous 2 years, including but not limited to systemic lupus erythematosus or multiple sclerosis;
- History of immediate allergic reactions, eczema or asthma uncontrolled by topical corticosteroids;
- History of primary immunodeficiency;
- Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis;
- History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis;
- History of active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis);
- Patients with human immunodeficiency virus (HIV) positive;
- Active hepatitis B or C. Active hepatitis B is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above the upper limit of normal at the study site; Active hepatitis C is defined as positive hepatitis C antibody and HCV RNA level above the upper limit of normal at the study site;
- Patients with endocrine defects that have been controlled by hormone replacement therapy can be enrolled, such as type I diabetes, hypothyroidism, etc. The following patients should be evaluated for target organ involvement and the need for systemic therapy at the discretion of the investigator, such as patients with concurrent rheumatoid arthritis and other joint diseases, Sjogren's syndrome, celiac disease and psoriasis that have been controlled after topical medication, as well as patients with positive serological tests e.g. antinuclear antibodies (ANA), anti-thyroid antibodies, etc.;
- Other conditions are considered not suitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumors
This is an open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies or who have no standard therapy. It is planned to enroll 69-176 patients into the study.
- Conditions
- Advanced Tumors
- Being tested
- JS006 as Monotherapy, JS006 in combination with Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS006 as MonotherapyDrug
- JS006 as Monotherapy dose-escalation: JS006, 18/ 60/ 180/ 600/ 1800mg, IV infusion, every 3 weeks (q3w).
- JS006 as Monotherapy dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w).
JS006 in combination with ToripalimabDrug
- JS006 in combination with Toripalimab dose-escalation: JS006, 2 or 3 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).
- JS006 in combination with Toripalimab dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).
- JS006 in combination with Toripalimab indications expansion: JS006, RP2D, IV infusion, every 3 weeks(q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).
| Study group | Role | What they receive |
|---|---|---|
| JS006 as Monotherapy | Experimental | 1. JS006 as Monotherapy dose-escalation：5 proposed dose levels（18mg, 60mg, 180mg, 600mg, 1800mg).
2. JS006 as Monotherapy dose-extension：1 or 2 proposed dose levels, to be determined. Receives: Drug: JS006 as Monotherapy |
| JS006 in combination with Toripalimab | Experimental | 1. JS006 in combination with Toripalimab dose-escalation：2 or 3 proposed dose levels, to be determined.
2. JS006 in combination with Toripalimab dose-extension：1 or 2 proposed dose levels, to be determined.
3. JS006 in combination with Toripalimab indications expansion: 2 to 4 specific tumor types are selected for indication expansion after the combination dose-expansion is completed. Receives: Drug: JS006 in combination with Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Incidence and severity of dose limiting toxicity (DLT), adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); abnormal changes with clinical significance in the laboratory and other tests
Measured: 2 years
Determing the maximum tolerated dose and the recommended phase II dose for JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Maximum tolerated dose: Dose Limitted Toxictiy events occurred at a rate less than 1/3 of the maximum tolerated dose.
Phase II recommended dose: safety, pharmacokinetics, and preliminary efficacy data of dose escalation will be integrated. When the Maximum tolerated dose(MTD) is determined, the Maximum tolerated dose(MTD) is usually used as the Phase II recommended dose(RP2D), or the dose lower than the Maximum tolerated dose(MTD) is selected as the Phase II recommended dose(RP2D) based on the comprehensive data.
Measured: 2 years
Secondary outcomes (9)
Pharmacokinetic (PK) profile: JS006
JS006 concentrations in individual subjects at different time points after dosing of JS006.
Measured: 2 years
To determine the immunogenicity of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors
Immunogenicity: incidence of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs) of JS006 and toripalimab.
Measured: 2 years
Within 1 hour before the first administration to 90 ±7 days after the last administration.
Peripheral blood immune cell subset and receptor occupancy of TIGIT
Measured: 2 years
Objective response rate (ORR)
The percentage of cases with remission (PR + CR) after treatment was assessable.
Measured: 2 years
Duration of response (DOR)
The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause.
Measured: 2 years
Disease control rate (DCR)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Measured: 2 years
Time to response (TTR)
time from the start of treatment to progression of diease.
Measured: 2 years
Progression-free survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death.
Measured: 2 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
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 posted29 Sep 2021
- Study start21 Apr 2021
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061628
- Sponsor's protocol ID
- JS006-001-I
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumors
- ClinicalTrials.gov ID
- NCT05061628
- Acronym / sponsor ID
- JS006-001-I
- Conditions
- Advanced Tumors
- 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
- 21 Apr 2021 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 29 Sep 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.
This is an open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies or who have no standard therapy. It is planned to enroll 69-176 patients into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS006 as Monotherapy | Experimental | Drug: JS006 as Monotherapy1. JS006 as Monotherapy dose-escalation：5 proposed dose levels（18mg, 60mg, 180mg, 600mg, 1800mg). 2. JS006 as Monotherapy dose-extension：1 or 2 proposed dose levels, to be determined. |
| JS006 in combination with Toripalimab | Experimental | Drug: JS006 in combination with Toripalimab1. JS006 in combination with Toripalimab dose-escalation：2 or 3 proposed dose levels, to be determined. 2. JS006 in combination with Toripalimab dose-extension：1 or 2 proposed dose levels, to be determined. 3. JS006 in combination with Toripalimab indications expansion: 2 to 4 specific tumor types are selected for indication expansion after the combination dose-expansion is completed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understanding and signature of the informed consent form voluntarily;
- Age 18 - 75 years (inclusive), male or female;
- Pathologically confirmed advanced malignancy who have failed standard treatment or with no standard treatment available;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Expected survival ≥ 12 weeks;
Key exclusion criteria (23 listed)
- Known allergic to toripalimab or ingredients of JS006;
- Have received anti-TIGIT or related targets CD155, CD112 or CD113 antibody treatment in the past;
- Participation in other clinical studies within 4 weeks before the first dose, except for an observational (non-interventional) clinical study or follow-up period of an interventional study;
- Major surgery (as judged by the investigator) within 4 weeks before the first dose or in the recovery period of surgery;
- Received systemic anti-tumor therapy within 4 weeks before the first dose, such as chemotherapy (or within 6 weeks for the last chemotherapy with nitrosourea or mitomycin), radiotherapy, targeted therapy, immunotherapy or biological therapy. Received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose of JS006. Hormone therapy, such as insulin for diabetes, hormone replacement therapy, etc., is acceptable for non-tumor-related diseases. Local palliative treatment (such as local surgery or radiotherapy) for isolated lesions can be accepted without affecting the efficacy evaluation;
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 |
|---|---|---|
| JS006 as Monotherapy1. JS006 as Monotherapy dose-escalation: JS006, 18/ 60/ 180/ 600/ 1800mg, IV infusion, every 3 weeks (q3w). 2. JS006 as Monotherapy dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w). | Drug | JS006 as Monotherapy |
| JS006 in combination with Toripalimab1. JS006 in combination with Toripalimab dose-escalation: JS006, 2 or 3 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). 2. JS006 in combination with Toripalimab dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). 3. JS006 in combination with Toripalimab indications expansion: JS006, RP2D, IV infusion, every 3 weeks(q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). | Drug | JS006 in combination with Toripalimab |
Primary outcome
To evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Time frame: 2 years
Incidence and severity of dose limiting toxicity (DLT), adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); abnormal changes with clinical significance in the laboratory and other tests
Determing the maximum tolerated dose and the recommended phase II dose for JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Time frame: 2 years
Maximum tolerated dose: Dose Limitted Toxictiy events occurred at a rate less than 1/3 of the maximum tolerated dose. Phase II recommended dose: safety, pharmacokinetics, and preliminary efficacy data of dose escalation will be integrated. When the Maximum tolerated dose(MTD) is determined, the Maximum tolerated dose(MTD) is usually used as the Phase II recommended dose(RP2D), or the dose lower than the Maximum tolerated dose(MTD) is selected as the Phase II recommended dose(RP2D) based on the comprehensive data.
9 secondary outcomes
Pharmacokinetic (PK) profile: JS006
Time frame: 2 years
To determine the immunogenicity of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors
Time frame: 2 years
Within 1 hour before the first administration to 90 ±7 days after the last administration.
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
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 9 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS006 as Monotherapy and JS006 in combination with Toripalimab in people with Advanced 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 9 inclusion and 23 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 9 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 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 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 JS006 as Monotherapy and in combination with toripalimab in patients with advanced 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 9 Jul 2026.