NCT04843033UnknownPhase 1
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
Nanjing Sanhome Pharmaceutical, Co., Ltd.1 site in 1 country55 target enrollmentStarted: April 2, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose(MTD)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Daily oral administration of SH3809 tablet
Experimental
Intervention: SH3809 tablet (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose(MTD)
Time Frame: Within the first 28 days of consecutive treatment
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
Secondary Outcomes
- Tmax(4 weeks])
- Progression-free survival(PFS)(up to 12 months)
- Disease control rates(DCR)(up to 12 months)
- Overall Response Rate(ORR)(up to 12 months)
- Duration of response(DOR)(up to 12 months)
- T1/2(4 weeks)
- Area Under the Curve (AUC)(4 weeks)
- Cmax(4 weeks)
Investigators
Study Sites (1)
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