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Trial Title:
Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID:
NCT05997615
Condition:
Hormone-refractory Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Castration Resistant Prostatic Cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMX-500 (SAR446329)
Description:
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)
infusion
Arm group label:
Part 1: AMX-500 Monotherapy Dose Escalation
Arm group label:
Part 2: AMX-500 Monotherapy Dose Expansion
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).
Detailed description:
Duration of the study up to approximately 48 months.
Criteria for eligibility:
Criteria:
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
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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigational Site Number: 101
Address:
City:
New South Wales
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 100
Address:
City:
Victoria
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 251
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 250
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 254
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 252
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 253
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigational Site Number: 300
Address:
City:
London
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
August 10, 2023
Completion date:
September 29, 2027
Lead sponsor:
Agency:
Amunix, a Sanofi Company
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05997615
