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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)
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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)
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Secondary ID [1]
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U1111-1287-6968
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Secondary ID [2]
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TCD17896
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hormone-refractory Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of participants with Adverse Events (AEs)
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Assessment method [1]
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Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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Timepoint [1]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Primary outcome [2]
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Part 1: Incidence of Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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Timepoint [2]
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from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21
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Primary outcome [3]
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Part 2: Prostate-Specific Antigen (PSA) response rate
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Assessment method [3]
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defined as a = 50% reduction in PSA from baseline
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Timepoint [3]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Primary outcome [4]
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Part 2: Objective Response Rate (ORR)
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Assessment method [4]
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defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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Timepoint [4]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [1]
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Part 2: Number of participants with Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [2]
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Part 1: PSA response rate
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Assessment method [2]
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Timepoint [2]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [3]
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Part 1: Objective Response Rate (ORR)
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Assessment method [3]
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Timepoint [3]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [4]
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All parts: Time to Response
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Assessment method [4]
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Time from the start of treatment to the first objective tumor response observed for participants who achieved confirmed Complete Response or Partial Response
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Timepoint [4]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [5]
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All parts: Duration of response (DoR)
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Assessment method [5]
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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.
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Timepoint [5]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [6]
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All parts: Progression Free Survival PFS
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Assessment method [6]
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Time from treatment initiation to disease progression using RECIST v1.1
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Timepoint [6]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [7]
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All parts: Assessment of PK parameters: Cmax
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Assessment method [7]
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Maximum plasma concentration observed
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Timepoint [7]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [8]
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All parts: Assessment of PK parameters: AUC
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Assessment method [8]
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Area under the concentration versus time curve
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Timepoint [8]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [9]
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All parts: Assessment of PK parameters: Tmax
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Assessment method [9]
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Time to reach Cmax
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Timepoint [9]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [10]
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All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500
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Assessment method [10]
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Incidence of patients with baseline anti-drug antibodies to AMX-500
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Timepoint [10]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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Secondary outcome [11]
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All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500
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Assessment method [11]
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Incidence of patients with treatment emergent anti-drug antibodies to AMX-500
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Timepoint [11]
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from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/09/2027
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Actual
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Sample size
Target
215
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number: 101 - New South Wales
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Recruitment hospital [2]
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Investigational Site Number: 100 - Victoria
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Recruitment postcode(s) [1]
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2010 - New South Wales
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Recruitment postcode(s) [2]
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3000 - Victoria
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Barcelona
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Country [2]
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Spain
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State/province [2]
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Madrid
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Country [3]
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Spain
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State/province [3]
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Pamplona
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Country [4]
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United Kingdom
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State/province [4]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amunix, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT05997615
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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