Actively Recruiting
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2022-09-06
122
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed non-Hodgkin lymphoma
- Relapsed or refractory solid tumor or non-Hodgkin lymphoma progressing during or after standard therapy, or when standard treatment is not tolerated, suitable, or available
- At least one evaluable or measurable lesion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as defined in the study protocol
- Meeting reproductive criteria as defined in the study protocol
You will not qualify if you...
- Clinically significant gastrointestinal abnormalities that may alter drug absorption
- Major surgery, systemic anti-cancer therapy, or investigational drug use within 4 weeks prior to study entry
- Radiation therapy within 2 weeks prior to study entry
- Adverse reactions from prior anti-tumor therapy not recovered to grade 1 or less (except hair loss; peripheral neurotoxicity recovered to grade 2 or less)
- Autologous hematopoietic stem cell transplantation within 9 months prior to 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 uncontrolled or symptomatic central nervous system metastases
- Known or suspected hypersensitivity to study medications
- Investigator judgment that patient should not participate
- Known mental illness or substance abuse that may interfere with therapy
- Clinically significant cardiac abnormalities as defined in the protocol
- Pregnant or breastfeeding women
- Pleural effusion, pericardial effusion, or ascites requiring diuretics or drainage within 2 weeks prior to first dose
- Current use of drugs that strongly inhibit or induce CYP3A4 enzyme
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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