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AMG 509 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: AMG 509 Intravenous (IV) Monotherapy | EXPERIMENTAL | Part 1 will evaluate AMG 509 in participants with metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with novel hormonal therapy (NHT) and 1 to 2 prior taxanes. The dose exploration phase of the study will estimate the maximum tolerated dose (MTD) of AMG 509 using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). Recommended phase 2 dose (RP2D) may be identified based on emerging safety, efficacy, PK, and pharmacodynamics (PD) data, as well as patient experience prior to reaching an MTD. Alternative dosing schedule(s) (including a third step dose) may be explored based on emerging efficacy, safety, PK data and patient experience. During the dose-expansion phase, individual cohorts of participants from China will be enrolled with a safety lead-in at 1 dose level below the MTD or RP2D followed by evaluation at the MTD or RP2D to confirm the safety, tolerability, MTD and/or RP2D of AMG 509 in Chinese participants. |
| Part 2: AMG 509 Subcutaneous (SC) Monotherapy | EXPERIMENTAL | Part 2 will explore the safety, tolerability, and PK of AMG 509 SC dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes. Recommended phase 2 dose for SC monotherapy may be identified based on emerging safety, efficacy, PK, and PD data, as well as patient experience prior to reaching an MTD. |
| Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment | EXPERIMENTAL | Part 3 will explore AMG 509 in participants with mCRPC who have received no, or 1-2 prior NHTs (may have been given for hormone-sensitive prostate cancer \[HSPC\]) and no prior taxanes (unless administered in HSPC setting). This dose-expansion will be conducted to confirm safety, PK, and PD of AMG 509 at the MTD or RP2D determined in Part 1 dose exploration, and to obtain further safety and efficacy data and correlative biomarker analysis. |
| Part 4: AMG 509 IV Combination Therapy | EXPERIMENTAL | Part 4 will explore the safety, tolerability, and PK of AMG 509 for participants with mCRPC who have received no or 1 to 2 prior NHTs given in any disease setting depending on the part (dose-expansion phase: prior therapies including at least 1 prior NHT and either 0 or 1 prior poly-ADP ribose polymerase \[PARP\] inhibitor), at dose regimens previously determined to be safe and tolerable in Part 1, in combination with abiraterone acetate (Part 4A) or enzalutamide (Part 4B) and no or 1 prior taxane for hormone sensitive disease in Parts 4A and 4B. |
| Part 5: AMG 509 IV Monotherapy in Outpatient Setting | EXPERIMENTAL | Part 5 will evaluate the safety and tolerability of AMG 509 IV dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes, when administered in outpatient infusion centers. The Part 5 dosing regimen and schedule was selected based on emerging data and dose level review team (DLRT) recommendations and will utilize the doses explored in Part 1 dose-expansion phase. |
| Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate | EXPERIMENTAL | Part 6 will evaluate the preliminary efficacy, safety, tolerability, and PK of AMG 509 (alone or in combination with abiraterone acetate) for participants with mCRPC who have progressed on only 1 prior NHT (prior exposure to ≤ 6 cycles of taxane is allowed in mHSPC setting) and who have Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable disease. Part 6 dosing regimen has been previously determined as safe and tolerable and is aligned with the dosing schedule for Parts 3 and 4A expansion. |
| Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate | EXPERIMENTAL | Part 7 will only include participants from China. This part will evaluate safety and tolerability of AMG 509 IV dosing in participants who have been previously treated with NHT and 1 to 2 prior taxanes. Part 7 dosing regime will first be enrolled to dose level-1 (1.0 mg target dose) and if tolerated and if DLRT determines it is safe to escalate to the MTD/RP2D, 1.5 mg every 2 weeks (Q2W) dosing regimen may be explored. If the RP2D is safe and tolerable and once AMG 509 monotherapy dose confirmation is complete, a cohort of participants to receive AMG 509 combination therapy with abiraterone acetate may be initiated. |
| Name | Type | Description |
|---|---|---|
| AMG 509 | DRUG | AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2). |
| Abiraterone | DRUG | Abiraterone administered as oral tablets. |
| Enzalutamide | DRUG | Enzalutamide administered as oral tablets. |
Inclusion Criteria: * Parts 1, 2, 5 and 7: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed a...
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AMG 509 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in a clinical trial enrolling male participants aged 18 years and older.
AMG 509 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting a Phase 1 clinical trial of AMG 509 in participants with metastatic castration-resistant prostate cancer.
AMG 509 is in Phase 1 clinical development. It is an investigational drug being studied for metastatic castration-resistant prostate cancer and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants.
AMG 509 is being studied in a single active Phase 1 clinical trial with the identifier NCT04221542. This trial is titled 'Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer' and is recruiting participants in multiple countries including the United States, Australia, China, Germany, Japan, Portugal, South Korea, Spain, Switzerland, and Taiwan.
The Phase 1 clinical trial of AMG 509 (NCT04221542) is a randomized, controlled study. It is not double-blinded, meaning that participants and investigators may know which treatment is being administered. The trial is enrolling approximately 479 male participants with metastatic castration-resistant prostate cancer.