A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
NCT05528055 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2022-09-06
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
- 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
Sponsors & Collaborators
-
Jiangsu Simcere Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-18
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
Countries
- China
Study Locations
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