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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SCR-6920 capsule
  • SCR-6920 capsule
  • SCR-6920 capsule
  • SCR-6920 capsule

Treatment groups

122 Participants
are divided into 4 treatment groups