A Study to Investigate Safety and Tolerability of SH3809 Tablet in Patients With Advanced Solid Tumors

NCT ID: NCT04843033

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2023-12-31

Brief Summary

The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.

Detailed Description

This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daily oral administration of SH3809 tablet

Group Type: EXPERIMENTAL

SH3809 tablet

Intervention Type: DRUG

Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.

Interventions

SH3809 tablet

Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 75 years inclusive;

2. Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

4. Life expectancy ≥ 3 months;

5. Adequate hematologic, hepatic and renal function;

6. Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;

7. Provision of signed and dated, written informed consent prior to any study-specific evaluation.

Exclusion Criteria

1. Previous treatment with any SHP2 inhibitors;

2. Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;

3. Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;

4. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);

5. Patients who have impaired cardiac function or clinically significant cardiac diseases;

6. Active, clinically significant interstitial lung disease or pneumonitis;

7. Females who are pregnant or breastfeeding;

8. Judgment by the investigator that the patient should not participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sanhome Pharmaceutical, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shun Lu, Ph D

Role: CONTACT

shunlu_shchest@sina.com

22200000-3123

Facility Contacts

Shun Lu, Ph D

Role: primary

shunlu_shchest@sina.com

22200000-3123

Other Identifiers

SHC024-I-01

Identifier Type: -

Identifier Source: org_study_id