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

Phase 1

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SH3809 tablet

• Registration Number: NCT04843033
• Lead Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-02
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Last Update Submitted: 2021-04-09
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daily oral administration of SH3809 tablet	SH3809 tablet	-

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities (DLTs)	Within the first 28 days of consecutive treatment	Incidence and nature of DLTs in the dose escalation phase
Maximum tolerated dose(MTD)	Within the first 28 days of consecutive treatment

Secondary Outcome Measures

Name	Time	Method
Tmax	4 weeks]	Time of highest observed plasma concentration of SH3809
Progression-free survival(PFS)	up to 12 months
Disease control rates(DCR)	up to 12 months	Disease control rates of SH3809 per RECIST v1.1
Duration of response(DOR)	up to 12 months	Duration of response of SH3809 per RECIST v1.1
T1/2	4 weeks	Elimination half-life of SH3809
Area Under the Curve (AUC)	4 weeks	Area under the plasma concentration time curve of SH3809
Cmax	4 weeks	Highest observed plasma concentration of SH3809
Overall Response Rate(ORR)	up to 12 months	Overall response rate of SH3809 per RECIST v1.1

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China