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Tests treatment safety and results for Solid Tumor
Official title A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT05528055
What this study is testing
What is SCR-6920 capsule?
SCR-6920 capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor.
Also referred to as PRMT5 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- At least one evaluable or measurable lesion (as defined in the protocol).
- ECOG Performance Status 0 or 1.
- Life expectancy ≥12 weeks.
You likely can't join if
- 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...
- Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by...
- 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).
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.