Colorectal Cancer, Gastric Cancer
Conditions
Brief summary
This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
Interventions
DRUGSHR-A1811
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. * At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. * Has an ECOG PS 0-1. * Has a life expectancy of ≥ 3 months. * Has adequate organ function
Exclusion criteria
* Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. * Has received HER2 antibody drug conjugates,. * Central nervous system metastasis or meningeal metastasis with clinical symptoms * Has active infection requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT and the recommended Phase 2 dose (RP2D) | Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21). |
Countries
China
Outcome results
None listed