We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05356741
Recruitment Status : Recruiting
First Posted : May 2, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Amunix, a Sanofi Company )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of AMX-818 as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts:

  • Part 1 (dose escalation): Single-agent AMX-818
  • Part 2 (dose escalation): AMX-818 plus pembrolizumab
  • Part 3 (dose expansion): Single-agent AMX-818
  • Part 4 (dose expansion): AMX-818 plus pembrolizumab

The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.


Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic HER2-Expressing Cancers Drug: AMX-818 Drug: Pembrolizumab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : December 9, 2026
Estimated Study Completion Date : December 9, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part 1 (dose escalation)
Participants will receive single-agent AMX-818
 Drug: AMX-818
Administered as IV infusion
Experimental: Part 2 (dose escalation)
Participants will receive AMX-818 plus pembrolizumab
 Drug: AMX-818
Administered as IV infusion

Drug: Pembrolizumab
Administered as IV infusion
Experimental: Part 3 (dose expansion)
Participants will receive single-agent AMX-818
 Drug: AMX-818
Administered as IV infusion
Experimental: Part 4 (dose expansion
Participants will receive AMX-818 plus pembrolizumab
 Drug: AMX-818
Administered as IV infusion

Drug: Pembrolizumab
Administered as IV infusion


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity - Part 1 and Part 2 [ Time Frame: Up to approximately 21 days (Part 1) and 42 days (Part 2) ]
  2. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 [ Time Frame: Up to approximately 55 months ]
  3. Objective Response Rate (ORR) - Part 3 and Part 4 [ Time Frame: Up to approximately 52 months ]
    ORR defined as a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

  4. Duration of Response (DOR) - Part 3 and Part 4 [ Time Frame: Up to approximately 52 months ]
    DOR defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v.1.1.


Secondary Outcome Measures :
  1. ORR - Part 3 and Part 4 [ Time Frame: Up to approximately 52 months ]
    ORR defined as defined as a Complete Response (CR) or Partial Response (PR) per Immune Response Evaluation Criteria in Solid Tumors (iRECIST).

  2. DOR - Part 3 and Part 4 [ Time Frame: Up to approximately 52 months ]
    DOR defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per iRECIST.

  3. Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  4. PK parameter: Maximum plasma concentration (Cmax) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  5. PK parameter: Minimum serum concentration (Cmin) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  6. PK parameter: Clearance (CL) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  7. PK parameter: Volume of distribution at steady-state (Vss) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  8. PK parameter: Accumulation ratio [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  9. PK parameter: Half-life (t1/2) [ Time Frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months ]
  10. Incidence of anti-drug antibodies (ADAs) to AMX-818 [ Time Frame: Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 52 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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 criteria:

  • 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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05356741


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Layout table for location information
Australia
Investigational site number #100 Recruiting
Melbourne, Australia, 3000
Investigational site number #101 Recruiting
Randwick, Australia, 2031
France
Investigational site number #150 Recruiting
Toulouse, France, 31059
Portugal
Investigational site number #200 Recruiting
Porto, Portugal, 4200-072
Spain
Investigational site number #255 Recruiting
Barcelona, Spain, 08023
Investigational site number #251 Recruiting
Barcelona, Spain, 08035
Investigational site number #254 Recruiting
Madrid, Spain, 28027
Investigational site number #252 Recruiting
Madrid, Spain, 28050
Investigational site number #250 Recruiting
Pamplona, Spain, 31008
Investigational site number #253 Recruiting
Pozuelo de Alarcón, Spain, 28223
Sponsors and Collaborators
Amunix, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Amunix, a Sanofi Company
ClinicalTrials.gov Identifier: NCT05356741    
Other Study ID Numbers: AMX-818-001
2021-004731-91 ( EudraCT Number )
TCD17730 ( Other Identifier: Sanofi )
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action