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Closed (no longer recruiting)Last updated: 7 February 2024

This phase I trial is evaluating how safe, tolerable and effective a targeted therapy (SHR-A1811) is in people with HER2 expressing or mutated advanced solid cancersA Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects

Clinical summary

Summary

This trial will be conducted in two parts to assess the safety, tolerability and activity of a new targeted therapy. Part 1 is a dose escalation phase, and participants will receive SHR-A1811 via intravenous infusion. Part 2 is an indication expansion phase, and participants will also receive SHR-A1811 via intravenous infusion.

Conditions

This trial is treating patients with HER2 expressing or mutated advanced solid cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Jiangsu HengRui Medicine Co., Ltd.

Scientific Title

A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects

Eligibility

Inclusion

  • Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • LVEF ≥ 50% by either ECHO or MUGA
  • Has adequate renal and hepatic function
  • Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion

  • History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
  • Known hereditary or acquired bleeding and thrombotic tendency

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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