Status:
COMPLETED
A Study of SHR-A1403 in Patients With Advanced Solid Tumor
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
SHR-A1403 is a humanized IgG2, anti-C-Met monoclonal antibody conjugated to microtubule inhibitor (c-Met ADC).The aim of this study is to assess the safety and tolerability of SHR-A1403，to define the ...
Detailed Description
This study is a phase I clinical trial of single arm，open-label，dose escalation with single and multiple doses.The safety,PK and preliminary efficacy of SHR-A1403 were evaluated respectively in the pa...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at both the Screening and baseline visits;
- Life expectancy ≥12 weeks
- Diagnosed (histologically or cytologically) with solid tumors and documented as advanced or metastatic disease for which there is no known effective anti-tumor treatment (refractory to or relapsed from standard therapies);
- Subjects must have measurable lesion(s) per RECIST v1.1 guideline at the Screening visit.
- Adequate laboratory parameters during the Screening Period as evidenced by:
- Absolute neutrophil count (ANC)≥1.5×109/L (1,500/mm3)；
- Platelets ≥100×109/L (100,000/mm3)；
- Hemoglobin (Hgb) ≥9.0 g/dL (90 g/L)；
- Albumin levels ≥2.8 g/dL；
- Total bilirubin ≤1.5×ULN (≤3×ULN for subjects with liver metastases)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- 5×ULN; for subjects with liver metastases, ALT and AST ≤5×ULN；
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault equation；
- Subjects must have a washout period ≥4 weeks since the last dose of cytotoxic chemotherapy，non-cytotoxic chemotherapy(including any previous TKI treatment), any investigational therapy, any prior immuno-oncology or monoclonal antibody products administered and ≥6 weeks since the last dose of chemotherapy of mitomycin C or nitrosoureas prior to the first dose of SHR-A1403;
- Pregnancy and Contraception:
- Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment;
- Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of study drug;
- A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly);
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment and not be breast feeding. Female subjects of non-childbearing potential must be surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) OR naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at Screening of ≥40 mIU/mL;
- Willing and able to comply with clinic visits and study-related procedures;
- voluntarily participating in this clinical trial, understanding the study procedures and providing signed informed consent.
Exclusion
- Known history of Grade 3 or Grade 4 hypersensitivity to any components (antibody-drug conjugate \[ADC\], total antibody, unconjugated toxin) of the SHR-A1403 product, or sensitivity to humanized monoclonal antibody products);
- Any radiation or surgery within 4 weeks prior to the first dose of SHR-A1403, except for minor palliative intent(this is to be discussed with sponsor);
- Unresolved toxicities from previous anticancer therapy,defined as toxicities not yet resolved to NCI CTCAE (current version) grade ≤1 at baseline (other than alopecia and other tolerable AEs upon discussion with sponsor) . Subjects with chronic grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor;
- Central nervous system tumors or active central nervous system (CNS) metastasis by imaging diagnosis;
- Cardiac disease (New York Heart Association \[NYHA\] classes II-IV) including myocardial infarction,unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment within a minimum 6 months before enrollment;
- Active HBV and HCV infection (HBV virus copy number\>50 IU/mL, HCV virus RNA positive);
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune- deficient disease, or history of any organ transplantation;
- Any other medical(such as severe hypertension, diabetes, thyroid disease, etc.) or psychiatric or social condition deemed by the investigator to be likely serious hazards to a subject's rights, safety, welfare, or interfere with ability to sign informed consent, cooperate and participate in the study, interpret the results.
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03856541
Start Date
February 13 2019
End Date
May 7 2020
Last Update
October 28 2022
Active Locations (1)
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1
Shanghai Cancer Center, Fudan University
Shanghai, China, 200032