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A Phase I Study of JS108 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601285
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Study Description
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Brief Summary:
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
Estimated Study Start Date : October 28, 2020
Estimated Primary Completion Date : November 23, 2022
Estimated Study Completion Date : November 23, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)

Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort.

Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose.

Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose.


Outcome Measures
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Primary Outcome Measures :
  1. First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) [ Time Frame: A minimum of 21 days after first infusion of study drug ]
    Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

  2. Number of participants with adverse events (AEs) [ Time Frame: Through study completion, an average of 1 year ]
    The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.


Secondary Outcome Measures :
  1. Maximum observed serum or plasma concentration (Cmax) [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  2. Maximum serum drug time（Tmax） [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  3. Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf) [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  4. Volume of distribution at steady state (Vss) [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  5. Terminal phase elimination half life (t½) [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  6. Clearance (CL) [ Time Frame: Through study completion, an average of 1 year ]
    One of the pharmacokinetics parameters for JS108

  7. Anti-drug antibodies (ADA) [ Time Frame: Through study completion, an average of 1 year ]
    To evaluate the immunogenicity of JS108 in patients with advanced solid tumors

  8. Objective Response Rate (ORR) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]
    As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)

  9. Duration of response (DOR) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]
    DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.

  10. Progression Free Survival (PFS) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]
    PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.

  11. Overall Survival (OS) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]
    OS is defined as the time from the date of randomization to the date of death due to any cause.

  12. Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue [ Time Frame: Through study completion, an average of 1 year ]
    To investigate any potential correlations of Trop2 levels with responses and toxicity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Volunteer to sign an informed consent form.
  2. Age of 18-75 years (inclusive), male or female;
  3. Expected survival ≥3 months;
  4. Histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available;
  5. Toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the NCI-CTCAE v5.0, except alopecia;
  6. Subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with RECIST v 1.1;
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0 or 1;
  8. Subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study；
  9. The organ function level must meet the protocol requirements；
  10. Serum pregnancy test confirmed as negative for women of childbearing potential within 7
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601285


Contacts
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Contact: Lina Qin 86 18600672907 lina_qin@junshipharma.com

Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04601285    
Other Study ID Numbers: JS108-001-I
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms