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

Hormone-refractory Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997615
• Other study ID #: TCD17896
• Secondary ID: U1111-1287-6968A
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 10, 2023
• Est. completion date: September 29, 2027

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Duration of the study up to approximately 48 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: September 29, 2027
• Est. primary completion date: September 29, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hormone-refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AMX-500 (SAR446329)
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	Investigational Site Number: 101	New South Wales
Australia	Investigational Site Number: 100	Victoria
Spain	Investigational Site Number: 250	Barcelona
Spain	Investigational Site Number: 251	Barcelona
Spain	Investigational Site Number: 252	Madrid
Spain	Investigational Site Number: 254	Madrid
Spain	Investigational Site Number: 253	Pamplona
United Kingdom	Investigational Site Number: 300	London

Sponsors (1)

Lead Sponsor	Collaborator
Amunix, a Sanofi Company

Countries where clinical trial is conducted

Australia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Part 2: Number of participants with Adverse Events (AEs)		from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary	Part 1: PSA response rate		from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary	Part 1: Objective Response Rate (ORR)		from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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