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

• ClinicalTrials.gov Identifier: NCT04601285
• Recruitment Status: Not yet recruiting
• First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Information provided by (Responsible Party): Shanghai Junshi Bioscience Co., Ltd.

Tracking Information

• First Submitted Date: October 12, 2020
• First Posted Date: October 23, 2020
• Last Update Posted Date: October 23, 2020
• Estimated Study Start Date: October 28, 2020
• Estimated Primary Completion Date: November 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2020)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 19, 2020)

• Maximum observed serum or plasma concentration (Cmax) [ Time Frame: Through study completion, an average of 1 year ]
  One of the pharmacokinetics parameters for JS108
• Maximum serum drug time（Tmax） [ Time Frame: Through study completion, an average of 1 year ]
  One of the pharmacokinetics parameters for JS108
• 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
• Volume of distribution at steady state (Vss) [ Time Frame: Through study completion, an average of 1 year ]
  One of the pharmacokinetics parameters for JS108
• Terminal phase elimination half life (t½) [ Time Frame: Through study completion, an average of 1 year ]
  One of the pharmacokinetics parameters for JS108
• Clearance (CL) [ Time Frame: Through study completion, an average of 1 year ]
  One of the pharmacokinetics parameters for JS108
• 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
• 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)
• 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.
• 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.
• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase I Study of JS108 in Patients With Advanced Solid Tumors
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumors

Intervention

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.

Study Arms

Experimental: Dose Escalation

Intervention: Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 19, 2020): 153
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 23, 2022
• Estimated Primary Completion Date: November 23, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04601285
• Other Study ID Numbers: JS108-001-I
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
• Study Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai Junshi Bioscience Co., Ltd.
• Verification Date: September 2020