Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors
NCT Number: NCT06571422
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Malignant Solid Tumors
Interventions: DRUG: WJ47156|DRUG: JS001+Bevacizumab
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Collaborators: Sponsor GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 93
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-08
Completion Date: 2027-04-30
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).

Primary Outcome Measures: 1.DLT, Safety endpoints: incidence and severity of DLT, 1 years|2、AE, Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance, 2.5 years|3、SAE, Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance, 2.5 years|4.MTD, Maximum tolerated dose (MTD), 1 year|5.RP2D, Recommended dose for phase II trial, 1 year
Secondary Outcome Measures: 6.ORR, Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1, 2 years|7.DOR, Efficacy endpoints: Duration of response (DOR) per RECIST v1.1, 2 years|8.DCR, Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1, 2 years|9.PFS, Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1, 2 years|10.OS, Efficacy endpoints: Overall survival (OS), 2.5 years|11.Peak concentration（Cmax）, The pharmacokinetic parameters of WJ47156：peak concentration (Cmax), 2 years|12.The time to receive Cmax（Tmax）, The pharmacokinetic parameters of WJ47156 ：the time to receive Cmax（Tmax）, 2 years|13. Area under the plasma concentration-time curve (AUC0-t, AUC0-∞), The pharmacokinetic parameters of WJ47156 ：area under the plasma concentration-time curve (AUC0-t, AUC0-∞), 2 years|14.Apparent volume of distribution (Vd/F), The pharmacokinetic parameters of WJ47156 ：apparent volume of distribution (Vd/F), 2 years|15.Apparent clearance (CL/F), The pharmacokinetic parameters of WJ47156 ：apparent clearance (CL/F), 2 years|16.Terminal half-life (t1/2), The pharmacokinetic parameters of WJ47156 ：terminal half-life (t1/2), 2 years|17.Steady-state peak concentration(Cmax,ss), The pharmacokinetic parameters of WJ47156 ：steady-state peak concentration(Cmax,ss) for the main PK parameters for multiple dose, 2 years|18.Plasma trough concentration at steady state(Cmin,ss), The pharmacokinetic parameters of WJ47156 ：Plasma trough concentration at steady state(Cmin,ss) for the main PK parameters for multiple dose, 2 years|19.Mean plasma concentration at steady state(Cav,ss), The pharmacokinetic parameters of WJ47156 ：mean plasma concentration at steady state for the main PK parameters for multiple dose, 2 years|20.The time to receive Cmax at steady state（Tmax,ss）, The pharmacokinetic parameters of WJ47156 ：the time to receive Cmax at steady state（Tmax,ss）for the main PK parameters for multiple dose), 2 years|21.Area under the plasma concentration-time curve at steady state (AUC0-t, ss), The pharmacokinetic parameters of WJ47156 ：area under the plasma concentration-time curve at steady state (AUC0-t, ss)for the main PK parameters for multiple dose), 2 years|22.Accumulation factor(RAC), The pharmacokinetic parameters of WJ47156 ：accumulation factor(RAC) at steady state for the main PK parameters for multiple dose), 2 years|23.Fluctuation coefficient(FD), The pharmacokinetic parameters of WJ47156 ：fluctuation coefficient(FD) at steady state for the main PK parameters for multiple dose), 2 years
Other Outcome Measures: QT interval, To evaluate the correlation between plasma concentration of WJ47156 and QT interval (only applicable to the dose group of 30 mg and above of WJ47156 monotherapy), 2 years