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RecruitingLast updated:15 August 2023

MT-5111: This phase I/II is investigating the appropriate dose level and effectiveness of a new cancer drug (MT-5111) in people with HER2-positive solid cancersA Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

Clinical summary

Summary

This study will be conducted in two parts. Part 1 (dose escalation) aims to determine the recommended phase 2 dose (RP2D) to be used in Part 2. Part 1 will consist of participants with any type of HER2-positive solid cancer. Part 2 (dose expansion) aims to confirm how safe and tolerable the RP2D of MT-5111 is. Part 2 will consist of people with any type of HER2-positive solid cancers, including breast cancer, gastric or gastroesophageal adenocarcinomas. MT-5111 will be administered via intravenous infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

Age

People18+

Phase

I/II

Trial Acronym

MT-5111

More information

Trial Identifiers

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Commercial Sponsor

Molecular Templates, Inc.

Scientific Title

A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

Eligibility

Inclusion

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

Exclusion

  • 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.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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