Clinical trial NCT04843033: A Study to Investigate Safety and Tolerability of SH3809 Tablet in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: advanced solid tum
SHP2
EGFR
NSCLC
Colorectal cancer
KRAS G12
Lead sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Within the first 28 days of consecutive treatment
measure: Maximum tolerated dose(MTD)
timeFrame: Within the first 28 days of consecutive treatment
Secondary outcomes:
measure: Cmax
timeFrame: 4 weeks
measure: Tmax
timeFrame: 4 weeks]
measure: T1/2
timeFrame: 4 weeks
measure: Area Under the Curve (AUC)
timeFrame: 4 weeks
measure: Overall Response Rate(ORR)
timeFrame: up to 12 months
measure: Progression-free survival(PFS)
timeFrame: up to 12 months
measure: Disease control rates(DCR)
timeFrame: up to 12 months
measure: Duration of response(DOR)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: