A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
Overview
- Phase
- Phase 1
- Intervention
- SCR-6920 capsule
- Conditions
- Solid Tumor
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity(DLT)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Life expectancy ≥12 weeks.
- •Adequate organ function (as defined in the protocol).
- •Reproductive criteria (as defined in the protocol).
Exclusion Criteria
- •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.
- •History of a second malignancy within 2 years (as defined in the protocol).
- •Active uncontrolled or symptomatic lung disease (as defined in the protocol).
- •Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.
- •Known or suspected hypersensitivity to study medications.
- •Known active uncontrolled or symptomatic CNS metastases.
- •The investigator determined that the patient should not participate in the study.
Arms & Interventions
Dose escalation
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.
Intervention: SCR-6920 capsule
Dose expansion: non small cell lung cancer(NSCLC)
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose
Intervention: SCR-6920 capsule
Dose expansion: NHL
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Intervention: SCR-6920 capsule
Dose expansion: solid tumors
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Intervention: SCR-6920 capsule
Outcomes
Primary Outcomes
Dose limiting toxicity(DLT)
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).
Overall Response Rate (ORR)
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
Secondary Outcomes
- Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters.(Up to approximately 1 years)
- Pharmacokinetic Parameters: Area Under the Curve (AUC)(Up to approximately 1 years)
- Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions(Up to approximately 1 years)
- Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure(Up to approximately 1 years)
- Pharmacokinetic Parameters: Maximum Concentration (Cmax)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Trough Concentration (Ctrough)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Terminal elimination half life (t1/2)(Up to approximately 1 years)