Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined. |
|
| Dose expansion: non small cell lung cancer(NSCLC) | Experimental | Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose |
|
| Dose expansion: NHL | Experimental | Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis |
|
| Dose expansion: solid tumors | Experimental | Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCR-6920 capsule | Drug | SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 28 days |
| Overall Response Rate (ORR) | Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria | Up to approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SCR-6920 capsule | Drug | SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis |
|
|
| SCR-6920 capsule | Drug | SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis |
|
|
| SCR-6920 capsule | Drug | SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis |
|
|
| Up to approximately 1 years |
| 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. | Up to approximately 1 years |
| 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 | Up to approximately 1 years |
| Pharmacokinetic Parameters: Maximum Concentration (Cmax) | Blood samples will be collected at given time points to determine the Cmax of SCR-6920. | Up to approximately 1 years |
| Pharmacokinetic Parameters: Trough Concentration (Ctrough) | Blood samples will be collected at given time points to determine the Ctrough of SCR-6920. | Up to approximately 1 years |
| Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax) | Blood samples will be collected at given time points to determine the Tmax of SCR-6920. | Up to approximately 1 years |
| Pharmacokinetic Parameters: Terminal elimination half life (t1/2) | Blood samples will be collected at given time points to determine the t1/2 of SCR-6920. | Up to approximately 1 years |
| Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure | Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition. | Up to approximately 1 years |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided