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

NCT04843033 | Unknown Phase 1

• 1 other identifier: SHC024-I-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

advanced solid tum; SHP2; EGFR; NSCLC; Colorectal cancer; KRAS G12

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum tolerated dose(MTD)

  Within the first 28 days of consecutive treatment

Secondary Outcomes (8)

• Cmax

  4 weeks

• Tmax

  4 weeks]

• T1/2

  4 weeks

• Area Under the Curve (AUC)

  4 weeks

• Overall Response Rate(ORR)

  up to 12 months

Study Arms (1)

Daily oral administration of SH3809 tablet

EXPERIMENTAL

Drug: SH3809 tablet

Interventions

SH3809 tablet DRUG

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

Daily oral administration of SH3809 tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years inclusive;
• 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;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy ≥ 3 months;
• Adequate hematologic, hepatic and renal function;
• Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;
• Provision of signed and dated, written informed consent prior to any study-specific evaluation.

You may not qualify if:

• Previous treatment with any SHP2 inhibitors;
• 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;
• Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
• Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
• Patients who have impaired cardiac function or clinically significant cardiac diseases;
• Active, clinically significant interstitial lung disease or pneumonitis;
• Females who are pregnant or breastfeeding;
• Judgment by the investigator that the patient should not participate in the study.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Shun Lu, Ph D

CONTACT

22200000-3123; shunlu_shchest@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 13, 2021
• Study Start: April 2, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CN (1)