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A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor

NCT05015309 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-08-20

No results posted yet for this study

Summary

The primary objective is to determine the safety and tolerability of SH3765 in subjects with advanced malignant tumor by determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The second objective is to evaluate the PK profile and preliminary efficacy of SH3765 in subjects with advanced malignant tumor.

Conditions

  • Advanced Malignant Tumor

Interventions

DRUG

SH3765 tablet

Starting dose 2.5mg, oral administered once daily. If tolerated subsequent cohorts will test increasing doses (5mg, 10mg, 15mg, 20mg, 25mg, 30mg) of SH3765.

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-03-31
Completion
2024-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015309 on ClinicalTrials.gov