Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Malignant Solid Tumors
• Interventions: Drug: JS001+Bevacizumab; Drug: JS207; Drug: WJ47156

• Registration Number: NCT06571422
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Status Verified: 2024-10
• Study Start: 2024-10-23
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-05-15
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WJ47156+JS001+Bevacizumab	JS001+Bevacizumab	If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
WJ47146+JS207	JS207	If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
WJ47156	WJ47156	If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.

Primary Outcome Measures

Name	Time	Method
2、AE	2.5 years	Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance
1.DLT	1 years	Safety endpoints: incidence and severity of DLT
4.MTD	1 year	Maximum tolerated dose (MTD)
3、SAE	2.5 years	Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance
5.RP2D	1 year	Recommended dose for phase II trial

Secondary Outcome Measures

Name	Time	Method
19.Mean plasma concentration at steady state(Cav,ss)	2 years	The pharmacokinetic parameters of WJ47156 ：mean plasma concentration at steady state for the main PK parameters for multiple dose
7.DOR	2 years	Efficacy endpoints: Duration of response (DOR) per RECIST v1.1
9.PFS	2 years	Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1
13. Area under the plasma concentration-time curve (AUC0-t, AUC0-∞)	2 years	The pharmacokinetic parameters of WJ47156 ：area under the plasma concentration-time curve (AUC0-t, AUC0-∞)
16.Terminal half-life (t1/2)	2 years	The pharmacokinetic parameters of WJ47156 ：terminal half-life (t1/2)
14.Apparent volume of distribution (Vd/F)	2 years	The pharmacokinetic parameters of WJ47156 ：apparent volume of distribution (Vd/F)
22.Accumulation factor(RAC)	2 years	The pharmacokinetic parameters of WJ47156 ：accumulation factor(RAC) at steady state for the main PK parameters for multiple dose)
8.DCR	2 years	Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1
15.Apparent clearance (CL/F)	2 years	The pharmacokinetic parameters of WJ47156 ：apparent clearance (CL/F)
21.Area under the plasma concentration-time curve at steady state (AUC0-t, ss)	2 years	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)
6.ORR	2 years	Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1
10.OS	2.5 years	Efficacy endpoints: Overall survival (OS)
11.Peak concentration（Cmax）	2 years	The pharmacokinetic parameters of WJ47156：peak concentration (Cmax)
12.The time to receive Cmax（Tmax）	2 years	The pharmacokinetic parameters of WJ47156 ：the time to receive Cmax（Tmax）
20.The time to receive Cmax at steady state（Tmax,ss）	2 years	The pharmacokinetic parameters of WJ47156 ：the time to receive Cmax at steady state（Tmax,ss）for the main PK parameters for multiple dose)
23.Fluctuation coefficient(FD)	2 years	The pharmacokinetic parameters of WJ47156 ：fluctuation coefficient(FD) at steady state for the main PK parameters for multiple dose)
17.Steady-state peak concentration(Cmax,ss)	2 years	The pharmacokinetic parameters of WJ47156 ：steady-state peak concentration(Cmax,ss) for the main PK parameters for multiple dose
18.Plasma trough concentration at steady state(Cmin,ss)	2 years	The pharmacokinetic parameters of WJ47156 ：Plasma trough concentration at steady state(Cmin,ss) for the main PK parameters for multiple dose

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China