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

July 4, 2023 updated by: Shanghai Junshi Bioscience Co., Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
A minimum of 21 days after first infusion of study drug
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed serum or plasma concentration (Cmax)
Time Frame: Through study completion, an average of 1 year
One of the pharmacokinetics parameters for JS108
Through study completion, an average of 1 year
Maximum serum drug time（Tmax）
Time Frame: Through study completion, an average of 1 year
One of the pharmacokinetics parameters for JS108
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
Time Frame: Through study completion, an average of 1 year
One of the pharmacokinetics parameters for JS108
Through study completion, an average of 1 year
Terminal phase elimination half life (t½)
Time Frame: Through study completion, an average of 1 year
One of the pharmacokinetics parameters for JS108
Through study completion, an average of 1 year
Clearance (CL)
Time Frame: Through study completion, an average of 1 year
One of the pharmacokinetics parameters for JS108
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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)
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
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.
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
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.
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
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.
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
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS108-001-I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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