A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

NCT ID: NCT05528055

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2027-10-31

Brief 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).

Conditions

Solid Tumor; Non Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalation

Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined.

Group Type: EXPERIMENTAL

SCR-6920 capsule

Intervention Type: DRUG

SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis

Dose expansion: non small cell lung cancer(NSCLC)

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose

Group Type: EXPERIMENTAL

SCR-6920 capsule

Intervention Type: DRUG

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Dose expansion: NHL

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis

Group Type: EXPERIMENTAL

SCR-6920 capsule

Intervention Type: DRUG

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Dose expansion: solid tumors

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis

Group Type: EXPERIMENTAL

SCR-6920 capsule

Intervention Type: DRUG

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Interventions

SCR-6920 capsule

SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis

Intervention Type: DRUG

SCR-6920 capsule

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Intervention Type: DRUG

SCR-6920 capsule

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Intervention Type: DRUG

SCR-6920 capsule

SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Intervention Type: DRUG

Other Intervention Names

PRMT5 inhibitor; PRMT5 inhibitor; PRMT5 inhibitor; PRMT5 inhibitor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jinming Yu

Role: primary

sdyujinming@126.com

0531-67626971

Other Identifiers

SIM1907-04-PRMT5-101

Identifier Type: -

Identifier Source: org_study_id