Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Amunix

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hormone-refractory Prostate Cancer

Treatments: Drug: AMX-500 (SAR446329)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05997615

2023-503495-24 (Registry Identifier)

AMX-500-001 (Other Identifier)

TCD17896

U1111-1287-6968 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

Duration of the study up to approximately 48 months.

Enrollment: 215 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Part 1: AMX-500 Monotherapy Dose Escalation

Experimental group

Description:

AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle

Treatment:

Drug: AMX-500 (SAR446329)

Part 2: AMX-500 Monotherapy Dose Expansion

Experimental group

Description:

AMX-500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle

Treatment:

Drug: AMX-500 (SAR446329)