acapatamab for Prostate Cancer

Phase-Based Progress Estimates

Effectiveness

Safety

Prostate Cancer+2 More

acapatamab - Drug

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Eligibility

18+

Male

What conditions do you have?

Select

Eligibility

18+

Male

What conditions do you have?

Select

Study Summary

This trial is testing a new drug for prostate cancer that has spread and is no longer responding to hormone therapy. The goal is to find the maximum tolerated dose and to see if the drug is effective.

Eligible Conditions

Prostate Cancer
Castration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prostate Cancer

Cendakimab

FT-7051

AMG 509

Study Objectives

6 Primary · 32 Secondary · Reporting Duration: Up to 3 years

Up to 3 years

1, 2 and 3-year overall survival (OS)

Accumulation ratio of acapatamab

Area under the concentration-time curve (AUC) over the dosing interval of acapatamab

Area under the concentration-time curve over a 24-hour period (AUC24) of acapatamab when administered with CYP enzymes

Change in time to progression (radiographic and PSA)

Duration of response (DOR) (radiographic and PSA)

Half-life of acapatamab

Half-life of acapatamab when administered with CYP enzymes

Maximum serum concentration (Cmax) of acapatamab

Maximum serum concentration (Cmax) of acapatamab when administered with CYP enzymes

Minimum serum concentration (Cmin) of acapatamab

Number of participants with clinically significant changes in clinical laboratory tests

Number of participants with clinically significant changes in electrocardiogram (ECG)

Number of participants with clinically significant changes in vital signs

Number of participants with dose-limiting toxicity

Number of participants with treatment-emergent adverse events

Number of participants with treatment-related adverse events

Objective response (OR)

Other PCWG3-recommended endpoints - alkaline phosphatase [total, bone] levels

Hemoglobin

Other PCWG3-recommended endpoints - hemoglobin levels

Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH]

Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH] levels

Other PCWG3-recommended endpoints - neutrophil-to-lymphocyte ratio

Other PCWG3-recommended endpoints - time to symptomatic skeletal events

Other PCWG3-recommended endpoints - urine N-telopeptide

Other PCWG3-recommended endpoints - urine N-telopeptide levels

Other PCWG3-recommended endpoints alkaline phosphatase [total, bone]

Percentage of participants experiencing a response based on 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) response evaluations

Percentage of participants experiencing a response based on 68Gallium (68Ga)-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) response evaluations

Percentage of participants experiencing circulating tumor cells (CTC) response

Progression-free survival (PFS) (radiographic and PSA)

Prostate-specific antigen (PSA) response

Subject incidence of changes in pharmacokinetics - administration including accumulation following multiple dosing

Subject incidence of changes in pharmacokinetics - area under the concentration-time curve (AUC) over the dosing interval

Subject incidence of changes in pharmacokinetics - half-life

Subject incidence of changes in pharmacokinetics - maximum serum concentration (Cmax)

Serum

Trial Safety

Safety Progress

1 of 3

Other trials for Prostate Cancer

Cendakimab

FT-7051

AMG 509

Trial Design

7 Treatment Groups

Part 1 Dose-expansion: acapatamab treatment

1 of 7

Part 5: acapatamab Outpatient Cohort

1 of 7

Part 2: acapatamab + Pembrolizumab

1 of 7

Part 4: acapatamab 24 Hour Monitoring

1 of 7

Part 6: acapatamab + Cytochrome P450 (CYP) Cocktail Drug Interaction

1 of 7

Part 1 Dose-exploration: acapatamab treatment

1 of 7

Part 3: acapatamab + Etanercept Prophylaxis

1 of 7

Experimental Treatment

212 Total Participants · 7 Treatment Groups

Primary Treatment: acapatamab · No Placebo Group · Phase 1

Part 1 Dose-expansion: acapatamab treatment

Drug

Experimental Group · 1 Intervention: acapatamab · Intervention Types: Drug

Part 5: acapatamab Outpatient Cohort

Drug

Experimental Group · 1 Intervention: acapatamab · Intervention Types: Drug

Part 2: acapatamab + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, acapatamab · Intervention Types: Drug, Drug

Part 4: acapatamab 24 Hour Monitoring

Drug

Experimental Group · 1 Intervention: acapatamab · Intervention Types: Drug

Part 6: acapatamab + Cytochrome P450 (CYP) Cocktail Drug InteractionExperimental Group · 2 Interventions: Cytochrome P450 (CYP) Cocktail, acapatamab · Intervention Types: Drug, Drug

Part 1 Dose-exploration: acapatamab treatment

Drug

Experimental Group · 1 Intervention: acapatamab · Intervention Types: Drug

Part 3: acapatamab + Etanercept ProphylaxisExperimental Group · 2 Interventions: acapatamab, Etanercept · Intervention Types: Drug, Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Etanercept

FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: up to 3 years

Who is running the clinical trial?

AmgenLead Sponsor

1,291 Previous Clinical Trials

1,306,842 Total Patients Enrolled

12 Trials studying Prostate Cancer

4,630 Patients Enrolled for Prostate Cancer

MDStudy DirectorAmgen

834 Previous Clinical Trials

876,092 Total Patients Enrolled

7 Trials studying Prostate Cancer

4,535 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

Subjects must have undergone bilateral orchiectomy or must be on continuous ADT with a GnRH agonist or antagonist.

You have a total serum testosterone level of 50 ng/dL or 1.7 nmol/L.

You have a PSA level that has increased on at least 2 successive occasions at least 1 week apart.

The primary tumor must have nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications.

You have a performance status of 0 or 1.

You have a life expectancy of at least 6 months.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References