Clinical trial · Interventional
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor strategic decision
Summary
Brief summary (as posted)
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 340 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.
- interventionNames
- Drug: AMG 340
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
- interventionNames
- Drug: AMG 340
Primary outcomes (3)
- measure
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed prostatic adenocarcinoma. * History of metastatic disease. * Chemically or surgically castrate. * Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations. * Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. * Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate \[eGFR\] ≥ 50 mL/min, aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\] ≤ 3 x upper limit of normal \[ULN\], hemoglobin \[Hgb\] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm\^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count \[ANC\] ≥ 1500 / mm\^3). Exclusion Criteria: * Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen. * History of neuroendocrine differentiation in the subject's disease. * Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed. * Subject has clinically significant CNS pathology. * Subject requires chronic immunosuppressive therapy. * Subject has a history of major cardiac abnormalities.
References
Publications (0)
Data not yet available