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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

AMX-500 (SAR446329)

About this trial

This is an interventional treatment trial for Hormone-refractory Prostate Cancer focused on measuring Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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.

Sites / Locations

Investigational site number #100Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1: AMX-500 Monotherapy Dose Escalation

Part 2: AMX-500 Monotherapy Dose Expansion

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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)

Part 2: Prostate-Specific Antigen (PSA) response rate

defined as a ≥ 50% reduction in PSA from baseline

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)

Secondary Outcome Measures

Part 2: Number of participants with Adverse Events (AEs)

Part 1: PSA response rate

Part 1: Objective Response Rate (ORR)

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

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.

All parts: Progression Free Survival PFS

Time from treatment initiation to disease progression using RECIST v1.1

All parts: Assessment of PK parameters: Cmax

Maximum plasma concentration observed

All parts: Assessment of PK parameters: AUC

Area under the concentration versus time curve

All parts: Assessment of PK parameters: Tmax

Time to reach Cmax

All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500

Incidence of patients with baseline anti-drug antibodies to AMX-500

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

Full Information

NCT ID

NCT05997615

First Posted

July 24, 2023

Last Updated

September 29, 2023

Sponsor

Amunix, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT05997615

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 Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 10, 2023 (Actual)

Primary Completion Date

September 29, 2027 (Anticipated)

Study Completion Date

September 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amunix, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone-refractory Prostate Cancer

Keywords

Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1: AMX-500 Monotherapy Dose Escalation

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2: AMX-500 Monotherapy Dose Expansion

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMX-500 (SAR446329)

Intervention Description

Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

Primary Outcome Measure Information:

Title

Part 1: Number of participants with Adverse Events (AEs)

Description

Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

Part 1: Incidence of Dose Limiting Toxicities (DLTs)

Description

Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to Day 21

Title

Part 2: Prostate-Specific Antigen (PSA) response rate

Description

defined as a ≥ 50% reduction in PSA from baseline

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

Part 2: Objective Response Rate (ORR)

Description

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)

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Secondary Outcome Measure Information:

Title

Part 2: Number of participants with Adverse Events (AEs)

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

Part 1: PSA response rate

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

Part 1: Objective Response Rate (ORR)

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Time to Response

Description

Time from the start of treatment to the first objective tumor response observed for participants who achieved confirmed Complete Response or Partial Response

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Duration of response (DoR)

Description

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.

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Progression Free Survival PFS

Description

Time from treatment initiation to disease progression using RECIST v1.1

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Assessment of PK parameters: Cmax

Description

Maximum plasma concentration observed

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Assessment of PK parameters: AUC

Description

Area under the concentration versus time curve

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Assessment of PK parameters: Tmax

Description

Time to reach Cmax

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Incidence of baseline anti-drug antibodies (ADAs) to AMX-500

Description

Incidence of patients with baseline anti-drug antibodies to AMX-500

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

Title

All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to AMX-500

Description

Incidence of patients with treatment emergent anti-drug antibodies to AMX-500

Time Frame

from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Trial Transparency email recommended (Toll free for US & Canada)

Phone

800-633-1610

Ext

option 6

Email

Contact-US@sanofi.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational site number #100

City

Melbourne

ZIP/Postal Code

3000

Country

Australia

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Hormone-refractory Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial