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RecruitingLast updated: 2 February 2024

This phase I study is evaluating how safe and effective a new targeted therapy (AMX 818) is alone, or in combination with immunotherapy (pembrolizumab) in people with HER2+ cancersA Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX 818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Clinical summary

Summary

This dose escalation and dose expansion study has four parts. In Part 1 (dose escalation), participants will receive AMX 818 alone, administered via intravenous (IV) infusion. In Part 2 (dose escalation), participants will receive AMX 818 (via IV) in combination with pembrolizumab (via IV). In Part 3 (dose expansion), participants will receive AMX 818 alone, via IV, at the Recommended Phase 2 Dose. In Part 4 (dose expansion), participants will receive AMX 818 (via IV) at the recommended Phase 2 Dose in combination with pembrolizumab (via IV).

Conditions

This trial is treating patients with locally advanced or metastatic HER2+ cancers, such as breast. bladder, ovarian, pancreatic and stomach cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Amunix, a Sanofi Company

Scientific Title

A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX 818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Eligibility

Inclusion

  • Written informed consent by the participant (or legally acceptable representative if applicable)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests

Exclusion

  • Significant cardiopulmonary disease and recent cardiac events
  • History of major organ autoimmune diseases
  • Acute or chronic infections

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Inclusion

  • 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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Recruiting hospitals

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