Actively Recruiting
Phase 1 Study of SCR-6920 Capsule to Evaluate Safety, Tolerability, and Early Effects in Adults With Advanced Solid Tumors or RelapsedRefractory Non-Hodgkin Lymphoma
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2022-09-06
122
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and preliminary effectiveness of a drug called SCR-6920 capsule in adults with advanced malignant tumors, including solid tumors and relapsed or refractory non-Hodgkin lymphoma NHL. This Phase 1 study aims to find the highest safe dose and the recommended dose for further research while confirming how well patients tolerate the treatment and its early effects. Participants will receive the SCR-6920 capsule orally once daily. The study includes a dose escalation phase where doses increase until the maximum tolerated dose is found. After this, participants will receive the recommended Phase 2 dose on a continuous basis. Different groups include those with non-small cell lung cancer, NHL, and other solid tumors. During the study, participants will be monitored for dose-limiting toxicities over 28 days and overall response rates for up to one year. Researchers will assess side effects, changes in laboratory tests, vital signs, heart function, and organ health. Pharmacokinetic measurements such as drug concentration and elimination will also be tracked. The study may last up to approximately one year, with continuous safety and efficacy evaluations throughout.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
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