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

Simcere

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor

Non Hodgkin Lymphoma

Treatments

Drug: SCR-6920 capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT05528055

SIM1907-04-PRMT5-101

Details and patient eligibility

About

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).

Enrollment

122 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

122 participants in 4 patient groups

Dose escalation

Experimental group

Description:

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.

Treatment:

Drug: SCR-6920 capsule

Dose expansion: non small cell lung cancer(NSCLC)

Experimental group

Description:

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

Treatment:

Drug: SCR-6920 capsule

Dose expansion: NHL

Experimental group

Description:

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