Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-06 @ 12:44 PM
Study NCT ID:
NCT06954467
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma
Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
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）
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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, namely dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).Dose-finding phase: This phase was designed to initially evaluate the tolerability and safety of JS207 combined with JS007 in patients with advanced HCC, and to determine the expansion dose. JS207 was administered at a fixed dose of 10 mg/kg every 3 weeks (Q3W). A Bayesian optimal interval (BOIN) design was used to explore the dose and frequency of JS007 administration (every 3-week treatment cycle, with a DLT observation period of 21±3 days after the first dose). For subjects who received the initial dose of dose 1 (a single dose of 3 mg/kg, 1 mg/kg every 6 weeks starting cycle 5 \[Q6W\]), the results were according to the BOIN design: if the dose was judged to be increased, dose 2 (3 mg/kg Q6W, 1 mg/kg Q6W starting cycle 5) was used for subsequent subjects. Dose 3 (1 mg/kg Q3W, followed by 1 mg/kg Q6W from cycle 5) was used for subsequent subjects if dose reduction or maintenance was judged. Dose 2 or dose 3 was similarly explored using the BOIN design.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.
Randomized expansion phase: This phase was designed to initially evaluate the efficacy of JS207 alone or in combination with JS007 in the first-line treatment of subjects with advanced HCC, as well as to further evaluate their safety. The randomized expansion phase planned to enroll approximately 40 to 60 subjects who would be randomly assigned in A 1:1 ratio to receive JS207 plus JS007 (cohort A) or JS207 alone (cohort B). Randomization stratification factor: baseline AFP level (\<400ng/mL vs. ≥400ng/mL).Dose reductions or increases in JS207 and JS007 were not allowed during the study period, and drug interruptions or discontinuation were allowed. Neither JS207 nor JS007 was given for a maximum of 2 years. When a study drug was discontinued for any reason, the other study drugs could be continued.
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, namely dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).Dose-finding phase: This phase was designed to initially evaluate the tolerability and safety of JS207 combined with JS007 in patients with advanced HCC, and to determine the expansion dose. JS207 was administered at a fixed dose of 10 mg/kg every 3 weeks (Q3W). A Bayesian optimal interval (BOIN) design was used to explore the dose and frequency of JS007 administration (every 3-week treatment cycle, with a DLT observation period of 21±3 days after the first dose). For subjects who received the initial dose of dose 1 (a single dose of 3 mg/kg, 1 mg/kg every 6 weeks starting cycle 5 \[Q6W\]), the results were according to the BOIN design: if the dose was judged to be increased, dose 2 (3 mg/kg Q6W, 1 mg/kg Q6W starting cycle 5) was used for subsequent subjects. Dose 3 (1 mg/kg Q3W, followed by 1 mg/kg Q6W from cycle 5) was used for subsequent subjects if dose reduction or maintenance was judged. Dose 2 or dose 3 was similarly explored using the BOIN design.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.
Randomized expansion phase: This phase was designed to initially evaluate the efficacy of JS207 alone or in combination with JS007 in the first-line treatment of subjects with advanced HCC, as well as to further evaluate their safety. The randomized expansion phase planned to enroll approximately 40 to 60 subjects who would be randomly assigned in A 1:1 ratio to receive JS207 plus JS007 (cohort A) or JS207 alone (cohort B). Randomization stratification factor: baseline AFP level (\<400ng/mL vs. ≥400ng/mL).Dose reductions or increases in JS207 and JS007 were not allowed during the study period, and drug interruptions or discontinuation were allowed. Neither JS207 nor JS007 was given for a maximum of 2 years. When a study drug was discontinued for any reason, the other study drugs could be continued.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: