A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-A1811 for patients with advanced gastric cancer or colorectal cancer that express a protein called HER2. The main goal of the study is to find out how safe the treatment is, how well it works, and how the body processes the medication. The trial is currently active but not recruiting new participants, and it includes both men and women aged between 65 and 74 years, as well as younger individuals up to 39 years old.

To be eligible for this trial, patients must have advanced cancer that is hard to treat or has not responded to standard therapies. They should have at least one area of cancer that can be measured, and their overall health must be stable enough to participate. Participants can expect close monitoring throughout the study, including assessments of their health and the cancer's response to treatment. It's important to note that individuals with certain conditions, like unresolved side effects from past cancer treatments or ongoing infections, cannot join this trial.

Gender

ALL

Eligibility criteria

• 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.