NCT04513223CompletedPhase 1
Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country101 target enrollmentStarted: March 30, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- DLT and the recommended Phase 2 dose (RP2D)
Study Overview
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.
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
- •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.
- •Has an ECOG PS 0-
- •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 ≤
- •Has received HER2 antibody drug conjugates,.
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •Has active infection requiring systemic treatment.
Arms & Interventions
SHR-A1811
Experimental
Intervention: SHR-A1811 (Drug)
Outcomes
Primary Outcomes
DLT and the recommended Phase 2 dose (RP2D)
Time Frame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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