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

• Status: Recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.