AMG 509 for Prostate Cancer

Phase-Based Progress Estimates

Effectiveness

Safety

Prostate CancerAMG 509 - 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 to see if it is safe and tolerated by adults. They will also be trying to determine the highest dose of the drug that can be given without causing serious side effects.

Eligible Conditions

Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

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AMG 786

Losartan

Study Objectives

8 Primary · 19 Secondary · Reporting Duration: Year 1, 2, and 3

3 years

Accumulation following multiple dosing for AMG 509

Alkaline phosphatase (total, bone)

Area under the concentration-time curve (AUC) over the dosing interval for AMG 509

Circulating tumor cells response (CTC0)

Dose limiting toxicities (DLTs)

Duration of response (DOR) (radiographic and PSA)

Hemoglobin

Incidence of treatment-emergent adverse events

Incidence of treatment-related adverse events

Lactate dehydrogenase (LDH)

Maximum serum concentration (Cmax) for AMG 509

Minimum serum concentration (Cmin) for AMG 509

Neutrophil-to-lymphocyte ratio

Number of participants with changes in the clinical laboratory tests results

Number of participants with changes in the clinical laboratory tests results.

Number of participants with changes in the electrocardiogram (ECG) records

Number of participants with changes in the electrocardiogram (ECG) records.

Number of participants with changes in vital signs

Malignant Neoplasms

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

Prostate specific antigen (PSA) response

Rate of circulating tumor cells CTC conversion

Time to maximum serum concentration (Tmax) for AMG 509

Time to progression (radiographic and PSA)

Time to symptomatic skeletal events

Urine N-telopeptide

Year 1

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

Trial Safety

Safety Progress

1 of 3

Similar Trials

Tarlatamab

AMG 786

Losartan

Trial Design

7 Treatment Groups

Part 5: AMG 509 IV Monotherapy in Outpatient Setting

1 of 7

Dose expansion phase

1 of 7

Dose exploration phase

1 of 7

Part 1: AMG 509 Intravenous (IV) Monotherapy

1 of 7

Part 2: AMG 509 Subcutaneous (SC) Monotherapy

1 of 7

Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment

1 of 7

Part 4: AMG 509 IV Combination Therapy

1 of 7

Experimental Treatment

459 Total Participants · 7 Treatment Groups

Primary Treatment: AMG 509 · No Placebo Group · Phase 1

Part 5: AMG 509 IV Monotherapy in Outpatient Setting

Drug