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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3809 Tablet in Patients With Advanced Solid Tumors in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843033
• Other study ID #: SHC024-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: Nanjing Sanhome Pharmaceutical, Co., Ltd.
• Contact: Shun Lu, Ph D
• Phone: 22200000-3123
• Email: shunlu_shchest[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sanhome Pharmaceutical, Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities (DLTs)	Incidence and nature of DLTs in the dose escalation phase	Within the first 28 days of consecutive treatment
Primary	Maximum tolerated dose(MTD)		Within the first 28 days of consecutive treatment
Secondary	Cmax	Highest observed plasma concentration of SH3809	4 weeks
Secondary	Tmax	Time of highest observed plasma concentration of SH3809	4 weeks]
Secondary	T1/2	Elimination half-life of SH3809	4 weeks
Secondary	Area Under the Curve (AUC)	Area under the plasma concentration time curve of SH3809	4 weeks
Secondary	Overall Response Rate(ORR)	Overall response rate of SH3809 per RECIST v1.1	up to 12 months
Secondary	Progression-free survival(PFS)		up to 12 months
Secondary	Disease control rates(DCR)	Disease control rates of SH3809 per RECIST v1.1	up to 12 months
Secondary	Duration of response(DOR)	Duration of response of SH3809 per RECIST v1.1	up to 12 months