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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05997615




Registration number
NCT05997615
Ethics application status
Date submitted
24/07/2023
Date registered
18/08/2023

Titles & IDs
Public title
Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Scientific title
A Phase 1, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Secondary ID [1] 0 0
U1111-1287-6968
Secondary ID [2] 0 0
TCD17896
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone-refractory Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMX-500 (SAR446329)

Experimental: Part 1: AMX-500 Monotherapy Dose Escalation - AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle

Experimental: Part 2: AMX-500 Monotherapy Dose Expansion - AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle


Treatment: Drugs: AMX-500 (SAR446329)
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Primary outcome [2] 0 0
Part 1: Incidence of Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21
Primary outcome [3] 0 0
Part 2: Prostate-Specific Antigen (PSA) response rate
Timepoint [3] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Primary outcome [4] 0 0
Part 2: Objective Response Rate (ORR)
Timepoint [4] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [1] 0 0
Part 2: Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [2] 0 0
Part 1: PSA response rate
Timepoint [2] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [3] 0 0
Part 1: Objective Response Rate (ORR)
Timepoint [3] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [4] 0 0
All parts: Time to Response
Timepoint [4] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [5] 0 0
All parts: Duration of response (DoR)
Timepoint [5] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [6] 0 0
All parts: Progression Free Survival PFS
Timepoint [6] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [7] 0 0
All parts: Assessment of PK parameters: Cmax
Timepoint [7] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [8] 0 0
All parts: Assessment of PK parameters: AUC
Timepoint [8] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [9] 0 0
All parts: Assessment of PK parameters: Tmax
Timepoint [9] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [10] 0 0
All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500
Timepoint [10] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary outcome [11] 0 0
All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500
Timepoint [11] 0 0
from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Eligibility
Key inclusion criteria
* Has histological, pathological, and/or cytological confirmation of prostate adenocarcinoma OR metastatic disease typical of prostate cancer (ie, involving bone or pelvic lymph nodes or para-aortic lymph nodes)
* Has metastatic disease, defined by =1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging - Has documented progressive mCRPC
* Have been treated with = 1 prior taxane regimens (eg, docetaxel, cabazitaxel)
* Participants deemed unsuitable for standard of care
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Has a life expectancy more than 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components
* Has acute or chronic infections
* Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to AMX 500, per the Investigator
* Has lesions in proximity of vital organs
* Has known active CNS metastases and/or carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's 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
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
10/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/09/2027
Actual
Sample size
Target
215
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number: 101 - New South Wales
Recruitment hospital [2] 0 0
Investigational Site Number: 100 - Victoria
Recruitment postcode(s) [1] 0 0
2010 - New South Wales
Recruitment postcode(s) [2] 0 0
3000 - Victoria
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Barcelona
Country [2] 0 0
Spain
State/province [2] 0 0
Madrid
Country [3] 0 0
Spain
State/province [3] 0 0
Pamplona
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amunix, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05997615