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).
Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL
Relapsed/refractory solid tumor or relapsed/refractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.
At least one evaluable or measurable lesion (as defined in the protocol).
ECOG Performance Status 0 or 1.
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.
Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.
Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).
Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.
Sequential
SCR-6920 capsule
DrugSCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
SCR-6920 capsule
DrugSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsule
DrugSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsule
DrugSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Dose limiting toxicity(DLT)
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)
Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria
Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions
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)
Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters.
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.
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Blood samples will be collected at given time points to determine the AUC (0-t) and AUC (0-inf) of SCR-6920
Pharmacokinetic Parameters: Maximum Concentration (Cmax)
Blood samples will be collected at given time points to determine the Cmax of SCR-6920.
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