Spots Global Cancer Trial Database for Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

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Trial Identification

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

Official 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)

Study ID: NCT05997615

Conditions

Hormone-refractory Prostate Cancer

Interventions

AMX-500 (SAR446329)

Study Description

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).

Detailed Description: Duration of the study up to approximately 48 months.