Investigating SCR-6920 Capsule for Patients with Advanced Malignant Tumors
A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
This study is testing a new capsule called SCR-6920 to see if it is safe and can help patients with advanced tumors who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05528055 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label, multi-center study aims to evaluate the safety and tolerability of SCR-6920 capsules in patients with advanced malignant tumors, including solid tumors and relapsed/refractory non-Hodgkin lymphoma. The study will involve a dose escalation approach to identify the maximum tolerated dose and the recommended Phase 2 dose. Participants will be monitored for pharmacokinetics and preliminary efficacy to assess the treatment's potential benefits. The study is designed for patients who have not responded to standard therapies or for whom such therapies are not suitable.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma who have progressed after standard therapies.
Not a fit: Patients with significant gastrointestinal abnormalities or those who have recently undergone major surgery or systemic anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignancies who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting advanced malignancies have shown promise in identifying effective treatments.
Eligibility criteria
Show full inclusion / exclusion 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 1. * 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. * Known mental illness or substance abuse that may disrupt therapy. * Clinically significant cardiac abnormalities (as defined in the protocol). * Gestating or Lactating women. * Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose. * The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.