RecruitingPhase 2NCT06954467

JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma

A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma(HCC)


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

72 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC. The subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs — JS207 and JS007 — as a first treatment option for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be removed by surgery. Researchers want to see if this drug combination is effective and safe for patients who have not yet had systemic (whole-body) drug treatment. **You may be eligible if...** - You are 18 or older with confirmed advanced liver cancer (HCC) - Your cancer has been classified as intermediate or advanced stage and cannot be treated with surgery or local procedures - You have not previously received systemic drug therapy for liver cancer - Your liver is functioning reasonably well (Child-Pugh class A or B with a score of 7 or less) - You have at least one measurable tumor **You may NOT be eligible if...** - You have received prior immunotherapy or targeted therapy for liver cancer (except for certain drugs used after surgery, if stopped at least 90 days before) - Your liver function is significantly impaired - You have active autoimmune disease or certain other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJS207

10 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies.

DRUGJS007

Dose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage.


Locations(12)

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine City:Shanghai

Shanghai, Shanghai Municipality, China

Shanghai East Hospital,School of Medicine, Tongji University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06954467


Related Trials