Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Location status: Recruiting
NCT Number: NCT05528055
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250117, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
Other names: PRMT5 inhibitor
Time frame: 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).
Time frame: Up to approximately 1 years
Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria
Time frame: Up to approximately 1 years
All AEs, SAEs and dose modifications will be collected. Adverse events as characterized by type, severity, timing and relationship to study therapy. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: Up to approximately 1 years
Blood and urine samples will be collected for analysis of lab parameters. Vital signs, electrocardiogram (ECG), physical examinations and organ-specific parameters will be collected at specified time points. Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters will be reported.
Time frame: Up to approximately 1 years
Blood samples will be collected at given time points to determine the AUC (0-t) and AUC (0-inf) of SCR-6920
Time frame: Up to approximately 1 years
Blood samples will be collected at given time points to determine the Cmax of SCR-6920.
Time frame: Up to approximately 1 years
Blood samples will be collected at given time points to determine the Ctrough of SCR-6920.
Time frame: Up to approximately 1 years
Blood samples will be collected at given time points to determine the Tmax of SCR-6920.
Time frame: Up to approximately 1 years
Blood samples will be collected at given time points to determine the t1/2 of SCR-6920.
Time frame: Up to approximately 1 years
Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Industry
A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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