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A Phase I Clinical Study of JS004 Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors

Sponsor
Shanghai Junshi Bioscience Co., Ltd. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05427396
Collaborator
Sponsor GmbH (Other)
140
Enrollment
2
Locations
1
Arm
36.9
Anticipated Duration (Months)
70
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single GroupSingle Group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors
Anticipated Study Start Date :
Jul 4, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: JS004 200 mg in combination with Toripalimab Injection 240 mg was administered every 3 weeks

Drug: JS004
Usage and dosage: Inject 200mg once every 3 weeks

Drug: Toripalimab Injection
Usage and dosage: Inject 240mg once every 3 weeks

Outcome Measures

Primary Outcome Measures

  1. The incidence of adverse events (AE) and serious adverse events (SAE) were assessed [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

Secondary Outcome Measures

  1. OS [2 years]

    Duration of Response

  2. DOR [2 years]

    Duration of Response

  3. DCR [2 years]

    Disease Control Rate

  4. PFS [2 years]

    Progression-free survival

  5. ORR [2 years]

    Overall Response Rate

  6. TTR [2 years]

    Time to remission

  7. TTP [2 years]

    time to progression

  8. Concentration of JS004 & JS001in plasma [2 years]

    Plasma Concentration

  9. Number of Participants with ADA positive [2 years]

    Anti-drug antibody

  10. Number of Participants with Nab positive [2 years]

    Neutralizing antibody

Other Outcome Measures

  1. ORR [2 years]

    Objective response rate based on iRECIST criteria (Version 2017);

  2. DOR [2 years]

    duration of response based on iRECIST criteria (Version 2017);

  3. DCR [2 years]

    disease control rate based on iRECIST criteria (Version 2017);

  4. PFS [2 years]

    progression-free survival based on iRECIST criteria (Version 2017);

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Sign the informed consent form voluntarily;

  2. Patient (both sex) ≥ 18 and ≤70 years at the time of signing informed consent;

  3. Expected survival ≥ 3 months;

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

  5. Patients with advanced solid tumors confirmed histologically or cytologically

  6. At least one measurable lesion as a target lesion (RECIST v1.1 criteria);

  7. Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible; provide archived samples within 2 years for patients who cannot provide fresh biopsy samples before treatment;

  8. The subject has good organ function as indicated by screening laboratory results

  9. 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;

  10. Good compliance and cooperated with the follow-up.

Exclusion Criteria:

  1. 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);

  2. 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

  3. Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration

  4. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;

  5. Central nervous system metastases and/or cancerous meningitis

  6. Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis

  7. A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;

  8. 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

  9. Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;

  10. A positive result for human immunodeficiency virus (HIV) antibody test;

  11. Known active tuberculosis (TB).

  12. Live vaccine was administered within 4 weeks prior to 1st administration

  13. Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration

  14. Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;

  15. Pregnant or lactating woman;

  16. Known to be allergic to JS004 or toripalimab and its components; 14. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing Beijing China
2 Chongqing University Cancer Hospital Chongqing Chongqing China

Sponsors and Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.
  • Sponsor GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05427396
Other Study ID Numbers:
  • JS004-005-I
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jun 22, 2022