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Advanced Solid TumorPhase 1NCT04278859

Safety, Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA) for Injection in Subjects With Advanced Malignancies

A Phase 1 study testing Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion in people with Advanced Solid Tumor, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A 3-part (dose-escalation, dose-expansion and cohort-expansion) phase I clinical study of JS004 in subjects with advanced solid malignancies in China for the first time, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the MTD and RP2D. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion
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
28 Apr 2020to 13 Jul 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

  • Able to understand and willing to sign the Informed Consent Form;
  • 18-70 years(included), male or female;
  • Subjects with histologically or cytologically confirmed advanced solid tumor.
  • In Dose Escalation and Dose Expansion, patients must have received, or be ineligible for or intolerant of all available approved or standard therapies known to confer clinical benefit, or for whom no standard therapy exists; in Indication Extension, patients with advanced solid tumors, who must have received at least one line of therapy for advanced or metastatic disease, but are not required to have received all standard therapies known to confer clinical benefit;
  • ECOG performance status of 0 or 1;
  • Life expectancy ≥12 weeks;
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  • At least one measurable lesion per RECISTv1.1 and iRECIST;
  • Willingness to provide consent for fresh pre-treatment biopsies, or,an archival specimen could be required within two years prior to the first dose of study drug;
  • Adequate organ and marrow function per protocol specifically defined;
  • Females of childbearing potential ,and males who are sexually active with a female partner of childbearing potential, must use effective contraception from time of screening, and must agree to continue using such precautions for 3 months after the final dose of JS004; HCG testing will be conducted and negative result within 7 days before randomization for females of childbearing potential, and must not be breast-feeding;

Who cannot join

  • Known allergic reaction to any monoclonal antibody or the ingredients and compositions of JS004 .
  • Prior exposure to anti-BTLA, or anti-HVEM antibodies.
  • Concurrent enrollment in another clinical study within 4 weeks prior to first dose of JS004, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
  • Major surgery (as defined by the investigator) within 4 weeks prior to first dose of JS004 or still recovering from prior surgery.Any concurrent chemotherapy within 4 weeks prior to first dose of JS004 , radiotherapy, immunotherapy, or biologic therapy for cancer treatment. Traditional Chinese/Chinese Patent Medicine preparations within 2 weeks prior to first dose of JS004 for treating tumors approved by NMPA.Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable. Isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy) without influence in efficacy assessment.
  • Patients who have discontinued prior immune therapy due to immune mediated adverse reaction(s).
  • Current or prior use of immunosuppressive medication within 4 weeks prior to the first dose of JS004, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids not to exceed 10 mg/day of prednisone or equivalent.
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  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Receipt of live attenuated vaccination within 30 days of receiving JS004.
  • Two or more malignant tumors within 5 years prior to the first dose of JS004. Except the following conditions: radically cured early malignant tumor (carcinoma in situ or stage I tumor), for example, adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer.
  • Symptomatic or untreated central nervous system (CNS) metastases or requiring ongoing treatment for CNS metastases, including corticosteroids and antiepileptic agents. Subjects with previously treated brain metastases may participate unless clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging metastases, and are off steroids.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to NCI-CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by JS004 may be included (e.g., hearing loss) after consultation with the medical monitor.
  • Active or prior documented autoimmune disease, such as but not limited to systemic lupus erythematosus or multiple sclerosis, within the past 2 years.
  • History of anaphylaxis, eczema that cannot be controlled with topical corticosteroids, or asthma.
  • History of primary immunodeficiency.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, fever of unknown origin > 38.5 °C ( Subjects with tumorous fever will be determined by investigator), symptomatic congestive heart failure according to New York Heart Association (NYHA) Functional Classification ≥ 3, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis
  • Patients with known history of active tuberculosis, and drug-induced interstitial lung disease or pneumonitis ≥ Grade 2.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • Subjects who are known to be human immunodeficiency virus (HIV) positive.
  • Subjects with evidence of hepatitis B or C virus infection, unless their hepatitis is considered to have been cured. (Note that subjects with prior hepatitis B virus [HBV] infection, HBc Ab positive and HBs Ag negative at screening visit, must have HBV viral load [VL] less than the local normal range of study site before study enrollment; hepatitis C virus [HCV] infection must have, HCV RAV negative before study enrollment.
  • Pregnant or breastfeeding women.
  • Patients with vitiligo, alopecia and controlled endocrine deficiency by hormone replacement therapy, such as hypothyroidism, can be included. Patients with rheumatoid arthritis and other joint diseases, Schering's syndrome, chylosis and psoriasis that have been controlled with topical administration, and patients with positive serological tests such as antinuclear antibody (ANA) and antithyroid antibody, should be assessed whether target organs are affected and systemic treatment required. It is up to the investigator to determine if the patient could be enrolled or not.
  • Having other factors that may possibly cause halfway-termination of this study as judged by investigators, for example, which may influence the right \& benift、safety of subjects, incompliance with the protocol, the capability to be informed consent, and other medical (e.g. the conditions or disease of respiratory, metabolic, congenital, endocrine and central nervous system, etc), family or social factors.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijin, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase I Clinical Study of JS004, a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA), in Subjects With Advanced Solid Malignancies

A 3-part (dose-escalation, dose-expansion and cohort-expansion) phase I clinical study of JS004 in subjects with advanced solid malignancies in China for the first time, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the MTD and RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.

Being tested
Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion

What participants receive

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

  • Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusionBiological

    Also called TAB004

    Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion

Study groups in NCT04278859
Study groupRoleWhat they receive
0.3mg/kg repeat dose every 21 days up to 2 yearsExperimentalNot described
Receives: Biological: Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion
1 mg/kg repeat dose every 21 days up to 2 years;ExperimentalNot described
Receives: Biological: Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion
3 mg/kg repeat dose every 21 days up to 2 years;ExperimentalNot described
Receives: Biological: Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion
10 mg/kg repeat dose every 21 days up to 2 years;ExperimentalNot described
Receives: Biological: Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion

What is being measured

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

  1. DLT, MTD, Number of participants and severiaty with treatment-related Adverse events (AEs) as assessed by CTCAE v5.0

    DLT, MTD, Number of participants and severity with treatment-related Adverse events (AEs) as assessed by CTCAE v5.0

    Measured: 2 years

Secondary outcomes (15)

  1. ORR

    Objective Response Rate(ORR) by RECIST 1.1

    Measured: 2 years

  2. DOR

    Duration of Response (DOR) by RECIST 1.1

    Measured: 2 years

  3. DCR

    Disease Control Rate (DCR) by RECIST 1.1

    Measured: 2 years

  4. PFS

    Progression-free survival(PFS) by RECIST 1.1

    Measured: 2 years

  5. OS

    Overall survival(OS) by RECIST 1.1

    Measured: 2 years

  6. RO

    BTLA receptor of occupancy (RO) of blood

    Measured: 2 years

  7. Cmax

    Maximum Plasma Concentration(Cmax) after injection of JS004

    Measured: 2 years

  8. Tmax

    Perk Time(Tmax) after injection of JS004

    Measured: 2 years

  9. Area Under the Cure(AUC) after injection of JS004

    AUC

    Measured: 2 years

  10. t1/2 half life

    t1/2 after injection of JS004

    Measured: 2 years

  11. Plasma Clearance(CL)

    Plasma Clearance(CL) after injection of JS004

    Measured: 2 years

  12. Volume of distribution(V)

    Apparent volume of distribution after injection of JS004

    Measured: 2 years

  13. Cmin

    Minimum Plasma concentration(Cmin) of steady state after multiple dose injection of JS004

    Measured: 2 years

  14. volume of distribution of steady state (Vss)

    Apparent volume of distribution of steady state (Vss) after multiple dose injection of JS004

    Measured: 2 years

  15. ADA

    The presence of anti-drug antibody (ADA) after multiple dose injection of JS004

    Measured: 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 posted20 Feb 2020
  2. Study start28 Apr 2020
  3. Primary completion13 Jul 2023
  4. Study completion13 Jul 2023

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278859
Sponsor's protocol ID
JS004-001-I
Status last verified
Jun 2025
First submitted
18 Feb 2020
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion in people with Advanced Solid Tumor, 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 22 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 19 Jun 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 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?

DLT, MTD, Number of participants and severiaty with treatment-related Adverse events (AEs) as assessed by CTCAE v5.0 (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 NCT04278859.

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 19 Jun 2025.

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