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Trial Title:
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
NCT ID:
NCT05528055
Condition:
Solid Tumor
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SCR-6920 capsule
Description:
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous
basis
Arm group label:
Dose escalation
Other name:
PRMT5 inhibitor
Intervention type:
Drug
Intervention name:
SCR-6920 capsule
Description:
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on
a continuous basis
Arm group label:
Dose expansion: non small cell lung cancer(NSCLC)
Other name:
PRMT5 inhibitor
Intervention type:
Drug
Intervention name:
SCR-6920 capsule
Description:
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on
a continuous basis
Arm group label:
Dose expansion: NHL
Other name:
PRMT5 inhibitor
Intervention type:
Drug
Intervention name:
SCR-6920 capsule
Description:
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on
a continuous basis
Arm group label:
Dose expansion: solid tumors
Other name:
PRMT5 inhibitor
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).
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinming Yu
Phone:
0531-67626971
Email:
sdyujinming@126.com
Start date:
May 18, 2022
Completion date:
October 2027
Lead sponsor:
Agency:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528055
