Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05356741




Registration number
NCT05356741
Ethics application status
Date submitted
26/04/2022
Date registered
2/05/2022
Date last updated
7/06/2024

Titles & IDs
Public title
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
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
Secondary ID [1] 0 0
TCD17730
Secondary ID [2] 0 0
AMX-818-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic HER2-Expressing Cancers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMX-818
Treatment: Drugs - pembrolizumab

Experimental: Part 1 (dose escalation) - Participants will receive single-agent AMX-818

Experimental: Part 2 (dose escalation) - Participants will receive AMX-818 plus pembrolizumab

Experimental: Part 3 (dose expansion) - Participants will receive single-agent AMX-818

Experimental: Part 4 (dose expansion - Participants will receive AMX-818 plus pembrolizumab


Treatment: Drugs: AMX-818
Administered as IV infusion

Treatment: Drugs: pembrolizumab
Administered as IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicity - Part 1 and Part 2
Timepoint [1] 0 0
Up to approximately 21 days (Part 1) and 42 days (Part 2)
Primary outcome [2] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4
Timepoint [2] 0 0
Up to approximately 55 months
Primary outcome [3] 0 0
Objective Response Rate (ORR) - Part 3 and Part 4
Timepoint [3] 0 0
Up to approximately 52 months
Primary outcome [4] 0 0
Duration of Response (DOR) - Part 3 and Part 4
Timepoint [4] 0 0
Up to approximately 52 months
Secondary outcome [1] 0 0
ORR - Part 3 and Part 4
Timepoint [1] 0 0
Up to approximately 52 months
Secondary outcome [2] 0 0
DOR - Part 3 and Part 4
Timepoint [2] 0 0
Up to approximately 52 months
Secondary outcome [3] 0 0
Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC)
Timepoint [3] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [4] 0 0
PK parameter: Maximum plasma concentration (Cmax)
Timepoint [4] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [5] 0 0
PK parameter: Minimum serum concentration (Cmin)
Timepoint [5] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [6] 0 0
PK parameter: Clearance (CL)
Timepoint [6] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [7] 0 0
PK parameter: Volume of distribution at steady-state (Vss)
Timepoint [7] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [8] 0 0
PK parameter: Accumulation ratio
Timepoint [8] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [9] 0 0
PK parameter: Half-life (t1/2)
Timepoint [9] 0 0
Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [10] 0 0
Incidence of anti-drug antibodies (ADAs) to AMX-818
Timepoint [10] 0 0
Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 52 months
Secondary outcome [11] 0 0
All parts: Disease control rate (DCR)
Timepoint [11] 0 0
Up to approximately 52 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/08/2027
Actual
Sample size
Target
645
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational site number #100 - Melbourne
Recruitment hospital [2] 0 0
Investigational site number #101 - Randwick
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Toulouse
Country [2] 0 0
Portugal
State/province [2] 0 0
Porto
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid
Country [5] 0 0
Spain
State/province [5] 0 0
Pamplona
Country [6] 0 0
Spain
State/province [6] 0 0
Pozuelo de Alarcón

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amunix, a Sanofi Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05356741
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
contact-us@sanofi.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05356741