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RecruitingLast updated: 2 February 2024

AMG 509: This phase I trial is trying to understand how much immunotherapy is safe and effective for the treatment of castration-resistant prostate cancer that has spread to other parts of the bodyA Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

This is a dose exploration and expansion study. In the dose exploration phase, eligible patients will receive a short term intravenous (IV) infusion of AMG 509 to determine the recommended phase 2 dose (RP2D) or a maximum tolerate dose. In the dose expansion phase of the study, eligible patients will receive the RP2D of AMG 509, administered as a short term IV infusion. Dexamethasone will be administered in both the dose exploration and expansion phase, prior to cycle 1 dosing.

Conditions

This trial is treating patients with castration resistant prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

Trial Acronym

AMG 509

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • Parts 1, 2, and 5: 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 at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment.

    1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
    2. Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.
  • Parts 4A and 4B:

    1. Participants with histologically or cytologically confirmed mCRPC who have received no or 1 prior NHT (given in any disease setting), and no or 1 taxane (given for hormone sensitive prostate cancer).
    2. 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
    3. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
  • All parts:
  • Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
  • Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
  • Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:

    1. PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
    2. nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications.
    3. appearance of 2 or more new lesions in bone scan.
  • Eastern Cooperative Oncology Group performance status of 0-1.
  • Adequate organ function, defined as follows:

    1. Hematological function:

      1. absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
      2. platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
      3. hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
    2. Renal function:

      1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2.

    3. Hepatic function:

      1. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
      2. total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).
    4. Cardiac function:

      1. left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
      2. Baseline electrocardiogram (ECG) QTcF <= 470 msec.

Exclusion

  • Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
  • Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
  • Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
  • Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  • History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
  • Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist). Participants on a stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment are eligible.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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