Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
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 people with locally advanced or metastatic HER2+ cancers, such as breast. bladder, ovarian, pancreatic and stomach cancer
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 spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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