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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
Date last updated
7/05/2024

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 2
* 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
The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).

* Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation
* Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion

The study may subsequently continue via a protocol amendment with dose escalation of AMX-500 combinations (Part 3) followed by combination therapy dose expansion (Part 4).
Trial website
https://clinicaltrials.gov/study/NCT05997615
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05997615