A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
SCR-6920 capsule: SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
SCR-6920 capsule: SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsule: SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsule: SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Study 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).
Eligibility
Primary outcome measure(s)
- Dose limiting toxicity(DLT) — Up to 28 days
DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD). - Overall Response Rate (ORR) — Up to approximately 1 years
Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
More Jiangsu Simcere Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05528055 on ClinicalTrials.gov ↗ ← All trials in China