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

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ClinicalTrials.gov Identifier: NCT04843033
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: SH3809 tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

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.




Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Within the first 28 days of consecutive treatment ]
    Incidence and nature of DLTs in the dose escalation phase

  2. Maximum tolerated dose(MTD) [ Time Frame: Within the first 28 days of consecutive treatment ]

Secondary Outcome Measures :
  1. Cmax [ Time Frame: 4 weeks ]
    Highest observed plasma concentration of SH3809

  2. Tmax [ Time Frame: 4 weeks] ]
    Time of highest observed plasma concentration of SH3809

  3. T1/2 [ Time Frame: 4 weeks ]
    Elimination half-life of SH3809

  4. Area Under the Curve (AUC) [ Time Frame: 4 weeks ]
    Area under the plasma concentration time curve of SH3809

  5. Overall Response Rate(ORR) [ Time Frame: up to 12 months ]
    Overall response rate of SH3809 per RECIST v1.1

  6. Progression-free survival(PFS) [ Time Frame: up to 12 months ]
  7. Disease control rates(DCR) [ Time Frame: up to 12 months ]
    Disease control rates of SH3809 per RECIST v1.1

  8. Duration of response(DOR) [ Time Frame: up to 12 months ]
    Duration of response of SH3809 per RECIST v1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843033


Contacts
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Contact: Shun Lu, Ph D 22200000-3123 shunlu_shchest@sina.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Shun Lu, Ph D    22200000-3123    shunlu_shchest@sina.com   
Principal Investigator: Shun Lu, Ph D         
Sponsors and Collaborators
Nanjing Sanhome Pharmaceutical, Co., Ltd.
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Responsible Party: Nanjing Sanhome Pharmaceutical, Co., Ltd.
ClinicalTrials.gov Identifier: NCT04843033    
Other Study ID Numbers: SHC024-I-01
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing Sanhome Pharmaceutical, Co., Ltd.:
advanced solid tum
SHP2
EGFR
NSCLC
Colorectal cancer
KRAS G12
Additional relevant MeSH terms:
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Neoplasms