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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SH3809 tablet

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 Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shun Lu, Ph D; Phone Number: 22200000-3123; Email: shunlu_shchest@sina.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Shun Lu, Ph D; Phone Number: 22200000-3123; Email: shunlu_shchest@sina.com
      • Principal Investigator: Shun Lu, Ph D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily oral administration of SH3809 tablet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose(MTD)		Within the first 28 days of consecutive treatment
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: NSCLC; Colorectal cancer; EGFR; SHP2; KRAS G12; advanced solid tum
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHC024-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No