NCT05528055

A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma(NHL).

Conditions

• Solid Tumor
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	SCR-6920 capsule	SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
DRUG	SCR-6920 capsule	SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
DRUG	SCR-6920 capsule	SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
DRUG	SCR-6920 capsule	SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Timeline

• Start date: 2022-05-18
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2022-09-06
• Last updated: 2022-09-06

Locations

1 site across 1 country: China