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CompletedLast updated: 25 January 2024

CT855: This phase I trial is trying to determine whether or not the drug HMPL-453 is effective in treating patients with advanced cancers (excluding blood cancer)A Phase I, Open-label, Multi-center, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of HMPL-453 in Patients With Advanced Solid Malignancies

Clinical summary

Summary

This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in patients with advanced or metastatic solid malignancies who have failed or are intolerable to standard therapies or for whom no standard therapies exist. There are preliminary two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). We will decide whether to conduct stage 2 or not one month after the last patient included in stage 1.

Conditions

This trial is treating patients with advanced cancers (excluding blood cancer).

Cancer

Multi-Cancer Multi-Cancer

Age

People25+

Phase

I

Trial Acronym

CT855

More information

Trial Identifiers

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Trial sponsor

Hutchison Medipharma Limited

Scientific Title

A Phase I, Open-label, Multi-center, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of HMPL-453 in Patients With Advanced Solid Malignancies

Eligibility

Inclusion

  • In the dose escalation stage, patients with locally advanced, or metastatic solid tumor who have failed, or intolerable to, standard therapies or for whom no standard therapies exist will be enrolled.
  • In the dose expansion stage, patients with locally advanced, or metastatic solid tumor and FGFR dysregulation who have failed or intolerable to standard therapies or no standard therapies exist are to be enrolled.
  • In the dose escalation stage: evaluable or measurable disease according to RECIST Version 1.1. In the dose expansion stage: measurable disease according to RECIST Version 1.1.
  • Life expectancy of at least 12 weeks.
  • ECOG performance status of 0 or 1

Exclusion

  • Prior or current treatment with any selective FGFR inhibitor.

Inclusion

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

Clinical trials have complex eligibility criteria.

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