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

NCT04601285 | Terminated Phase 1

• 1 other identifier: JS108-001-I
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)

  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)

  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 Outcomes (12)

• Maximum observed serum or plasma concentration (Cmax)

  Through study completion, an average of 1 year

• Maximum serum drug time（Tmax）

  Through study completion, an average of 1 year

• Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)

  Through study completion, an average of 1 year

• Volume of distribution at steady state (Vss)

  Through study completion, an average of 1 year

• Terminal phase elimination half life (t½)

  Through study completion, an average of 1 year

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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

Interventions

JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) DRUG

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.

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 23, 2020
• Study Start: October 28, 2020
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CN (3)