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Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
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).
Study details:
Duration of the study up to approximately 48 months.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2023-08-10
Primary completion: 2027-09-29
Study completion finish: 2027-09-29
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05997615
Intervention or treatment
DRUG: AMX-500 (SAR446329)
Conditions
- • Hormone-refractory Prostate Cancer
Find a site
Closest Location:
Investigational Site Number: 101
Research sites nearby
Select from list below to view details:
Investigational Site Number: 101
New South Wales, Not Specified, Australia
Investigational Site Number: 100
Victoria, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part 1: AMX-500 Monotherapy Dose Escalation
| DRUG: AMX-500 (SAR446329)
|
EXPERIMENTAL: Part 2: AMX-500 Monotherapy Dose Expansion
| DRUG: AMX-500 (SAR446329)
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Part 1: Number of participants with Adverse Events (AEs) | Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| Part 1: Incidence of Dose Limiting Toxicities (DLTs) | Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21 |
| Part 2: Prostate-Specific Antigen (PSA) response rate | defined as a ≥ 50% reduction in PSA from baseline | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| Part 2: Objective Response Rate (ORR) | 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) | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Part 2: Number of participants with Adverse Events (AEs) | Not Specified | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| Part 1: PSA response rate | Not Specified | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| Part 1: Objective Response Rate (ORR) | Not Specified | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Time to Response | Time from the start of treatment to the first objective tumor response observed for participants who achieved confirmed Complete Response or Partial Response | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Duration of response (DoR) | 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. | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Progression Free Survival PFS | Time from treatment initiation to disease progression using RECIST v1.1 | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: Cmax | Maximum plasma concentration observed | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: AUC | Area under the concentration versus time curve | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: Tmax | Time to reach Cmax | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500 | Incidence of patients with baseline anti-drug antibodies to AMX-500 | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
| All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500 | Incidence of patients with treatment emergent anti-drug antibodies to AMX-500 | from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months |
Frequently Asked Questions
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