A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors (NCT04513223) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
China101 participantsStarted 2021-03-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
DLT and the recommended Phase 2 dose (RP2D)
Timeframe: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).