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Advanced Solid TumorsPhase 1NCT05502393

A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors

A Phase 1 study testing JS107, Toripalimab and Oxaliplatin in people with Advanced Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 20 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS107 monotherapy and combination with Toripalimab in patients with Advanced or Metastatic Solid Tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
JS107, Toripalimab and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
20 sitesChina
Study dates
26 Jul 2022to 31 Dec 2027
Phase
Phase 1
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

  • The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
  • Aged ≥18 years and ≤75 years when the subject signed the informed consent;
  • Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ;
  • Provide past tumor samples or fresh tumor tissue biopsy samples;
  • The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;
  • The expected survival is ≥3 months;
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  • There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria;
  • Any adverse events and/or complications resulting from prior treatment, including surgery or radiation therapy, that have been adequately resolved to level 0 or 1 (according to the NATIONAL Cancer Institute Standard for General Terminology of Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria; Any grade of hair loss/pigmentation and other long-term toxicity caused by treatment, except those that are irreversible and do not affect study dosing/compliance and patient safety at the discretion of the investigator;
  • Good organ function；
  • Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 6 months after the last dose. Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 6 months after the last dose.

Who cannot join

  • Prior treatment with drugs or other therapies targeting CLDN18.2;
  • A history of severe allergic reactions to other monoclonal antibodies or to any component of JS107, or to other drugs or excipients involved in the trial protocol ;
  • Received radiotherapy (except palliative radiotherapy for symptom control), chemotherapy, targeted therapy, endocrine therapy and other antitumor therapies, or other investigational drugs within 4 weeks before the administration of the first dose;
  • Received any monoclonal antibody or antibody conjugate within 4 weeks prior to administration of the first study drug or within 5 half-lives (depend on whichever is shorter);
  • Persons who have an immunodeficient disease or the other chronic immunosuppressive therapy, or who have received systemic immunomodulatory drugs (including, but not limited to, interferon or IL-2) within 14 days before first dose or within the 5 half-life of the drug (depend on whichever is longer), or received systemic glucocorticoid therapy (10mg daily of prednisone or equivalent glucocorticoids) or other systemic immunosuppressive therapy within 14 days before first dose;
  • Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose;
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  • Serious infection (CTCAE> grade 2) occurred within 14 days before the first dose;
  • Patients with other malignant tumors except for the tumor treated in the study within 5 years prior to the administration of the first study drug (exceptions included: cured malignancies that had not recurred within 3 years prior to study enrollment; Completely resected basal and squamous cell skin cancers; Complete resection of any type of carcinoma in situ, etc.);
  • Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug;
  • Weight loss 10% within 2 months before drug administration, or other indicators of severe malnutrition, or body mass index (BMI)<17.5 at the time of signing the informed consent.
  • The following conditions were present within 6 months prior to the first study dose: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure , hypertensive crisis, or hypertensive encephalopathy; patients with known hypertension, coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be treated with optimal stabilization as determined by the treating physician medical plan;
  • Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment;
  • Poorly controlled pain related;
  • The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be manifested by the onset of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth;
  • Active infection, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);
  • History of autoimmune disease;
  • Idiopathic pulmonary fibrosis, drug-induced pneumonia, machine-induced pneumonia (bronchiolitis obliterans), radioactive pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function ;
  • Pregnant or lactating women;
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Have serious psychological or mental abnormality, which affects the compliance of the subject to participate in this clinical study;
  • Participated in any other clinical trial within 28 days prior to the first administration of study drug;
  • Other conditions deemed inappropriate for study participation by the investigator.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Anyang Tumor Hospital

    An'yang, Henan, 455100

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247099

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • The First Affiliated Hospital of Henan University of Science and Technology

    Hangzhou, Zhejiang, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514000

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266061

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50011

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wuhan University People's Hospital

    Wuhan, Hebei, 430060

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430010

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 733000

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453003

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Solid Tumors

The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS107 monotherapy and combination with Toripalimab in patients with Advanced or Metastatic Solid Tumors.

Being tested
JS107, Toripalimab, Oxaliplatin, Capecitabine

What participants receive

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

  • JS107Drug

    JS107, i.v., q3w

  • ToripalimabDrug

    Toripalimab i.v., q3w

  • OxaliplatinDrug

    Oxaliplatin, i.v., q3w, for 6-8 cycles

  • CapecitabineDrug

    Capecitabine, orally, 1000mg/m² twice daily on days 1-14, q3w

Study groups in NCT05502393
Study groupRoleWhat they receive
JS107ExperimentalNot described
Receives: Drug: JS107
JS107 combination with ToripalimabExperimentalNot described
Receives: Drug: JS107; Drug: Toripalimab
JS107 combination with Toripalimab and XELOXExperimentalNot described
Receives: Drug: JS107; Drug: Toripalimab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

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

  1. MTD

    Determine maximum tolerated dose (MTD, if possible)

    Measured: Up to approximately 12 months from first patient in.

  2. RP2D

    Recommended phase II dose (RP2D) for JS107 monotherapy and combination therapy

    Measured: Up to approximately 24 months from first patient in.

Secondary outcomes (3)

  1. Drug concentrations

    Drug concentrations in individual subjects at different time points after dosing

    Measured: Up to approximately 24 months from first patient in.

  2. Immunogenicity

    Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples

    Measured: Up to approximately 24 months from first patient in.

  3. ORR

    Objective response rate (ORR) was assessed based on RECIST V1.1 criteria

    Measured: Up to approximately 24 months from first patient in.

Timeline

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

  1. First posted16 Aug 2022
  2. Study start26 Jul 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502393
Sponsor's protocol ID
JS107-001-I
Status last verified
Aug 2026
First submitted
10 Aug 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS107, Toripalimab and Oxaliplatin in people with Advanced Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 20 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 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

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?

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?

MTD (time frame: Up to approximately 12 months from first patient in.). 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?

On the ClinicalTrials.gov record for NCT05502393.

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 7 Aug 2026.

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