Actively Recruiting
A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of a drug called SCR-6920 capsule in adults with advanced malignant tumors, including solid tumors and relapsed or refractory non-Hodgkin lymphoma (NHL). This Phase 1 study aims to find the highest safe dose and the recommended dose for further research while confirming how well patients tolerate the treatment and its early effects. Participants will receive the SCR-6920 capsule orally once daily. The study includes a dose escalation phase where doses increase until the maximum tolerated dose is found. After this, participants will receive the recommended Phase 2 dose on a continuous basis. Different groups include those with non-small cell lung cancer, NHL, and other solid tumors. During the study, participants will be monitored for dose-limiting toxicities over 28 days and overall response rates for up to one year. Researchers will assess side effects, changes in laboratory tests, vital signs, heart function, and organ health. Pharmacokinetic measurements such as drug concentration and elimination will also be tracked. The study may last up to approximately one year, with continuous safety and efficacy evaluations throughout.
CONDITIONS
Brief 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 after or intolerant to standard therapy
- At least one measurable or evaluable tumor lesion
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as defined in the protocol
- Meeting reproductive criteria as defined in the protocol
You will not qualify if you...
- Clinically significant gastrointestinal issues affecting drug absorption
- Major surgery, systemic anti-cancer therapy, or investigational drugs within 4 weeks prior to study entry; radiation therapy within 2 weeks prior
- Unresolved adverse reactions from prior anti-tumor therapy above specified severity
- Autologous hematopoietic stem cell transplant within 9 months before first dose
- History of a second malignancy within 2 years
- Active uncontrolled or symptomatic lung disease
- Intracranial hypertension or active uncontrolled or symptomatic central nervous system metastases
- Known or suspected hypersensitivity to study medications
- Mental illness or substance abuse that may interfere with therapy
- Clinically significant cardiac abnormalities
- Pregnant or breastfeeding women
- Pleural, pericardial effusion, or ascites requiring intervention within 2 weeks prior to first dose
- Current use of strong CYP3A4 inhibitors or inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive the SCR-6920 capsule orally once daily at escalating doses until the maximum tolerated dose is reached, followed by continuous treatment at the recommended phase 2 dose.
Regular visits during dose escalation and continuous treatment
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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