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

Phase 1RecruitingNCT05528055

Jiangsu Simcere Pharmaceutical Co., Ltd.122 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Solid Tumor Non Hodgkin Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dose limiting toxicity(DLT)

DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD).

Time frame: Up to 28 days

Overall Response Rate (ORR)

Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria