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DRUG:

xaluritamig (AMG 509)

i
Other names: AMG 509, AMG509, AMG-509
Company:
Amgen, BeiGene, Xencor
Drug class:
CD3 agonist, STEAP1 inhibitor
Related drugs:
7d
New P3 trial • Metastases
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Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • xaluritamig (AMG 509)
2ms
Enrollment open • Metastases
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STEAP1 (STEAP Family Member 1)
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xaluritamig (AMG 509)
2ms
New P1 trial
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STEAP1 (STEAP Family Member 1)
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xaluritamig (AMG 509)
3ms
New P1 trial • Metastases
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STEAP1 (STEAP Family Member 1)
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xaluritamig (AMG 509)
4ms
Circulating tumour cell (CTC) enumeration and overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) treated with xaluritamig (ESMO 2024)
Xaluritamig showed prolonged OS relative to historic benchmarks in heavily pretreated pts with poor prognostic features. CTC enumeration is highly prognostic of OS at baseline, and CTC conversion and PSA declines may predict response from xaluritamig treatment. Further validation is warranted as CTCs may guide future clinical development of xaluritamig by early identifying the treatment benefit in pts.
Clinical • Circulating tumor cells • Tumor cell • Metastases
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STEAP1 (STEAP Family Member 1)
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CELLSEARCH®
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xaluritamig (AMG 509)
10ms
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=441, Recruiting, Amgen | Trial completion date: Mar 2028 --> Jul 2028
Trial completion date • Metastases
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STEAP1 (STEAP Family Member 1)
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Xtandi (enzalutamide capsule) • abiraterone acetate • xaluritamig (AMG 509)
11ms
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=441, Recruiting, Amgen | Trial completion date: Jun 2028 --> Mar 2028 | Trial primary completion date: Jun 2026 --> Mar 2026
Trial completion date • Trial primary completion date • Metastases
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STEAP1 (STEAP Family Member 1)
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Xtandi (enzalutamide capsule) • abiraterone acetate • xaluritamig (AMG 509)
1year
AMG 509 (Xaluritamig), an Anti-STEAP1 XmAb 2+1 T-cell Redirecting Immune Therapy with Avidity-Dependent Activity Against Prostate Cancer. (PubMed, Cancer Discov)
The avidity-driven activity of AMG 509 enables selectivity for tumor cells with high STEAP1 expression compared with normal cells. AMG 509 is the first STEAP1 TCE to advance to clinical testing, and we report a case study of a mCRPC patient who achieved an objective response on AMG 509 treatment.
Journal
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STEAP1 (STEAP Family Member 1)
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STEAP1 expression
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xaluritamig (AMG 509)
1year
Xaluritamig, a STEAP1 × CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study. (PubMed, Cancer Discov)
Xaluritamig demonstrated encouraging responses (PSA and RECIST) compared with historical established treatments for patients with late-line mCRPC. This study provides proof of concept for T-cell engagers as a potential treatment for prostate cancer, validates STEAP1 as a target, and supports further clinical investigation of xaluritamig in prostate cancer.
P1 data • Journal • Metastases
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STEAP1 (STEAP Family Member 1)
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STEAP1 expression
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xaluritamig (AMG 509)
1year
Interim results from a phase I study of AMG 509 (xaluritamig), a STEAP1 x CD3 XmAb 2+1 immune therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) (ESMO Asia 2023)
Preliminary PK showed dose-proportional increase in exposure with a mean terminal half-life of approximately 3-4 days. Conclusions Xaluritamig was tolerable with low-grade CRS (occurring primarily cycle 1) with encouraging preliminary efficacy in heavily pretreated pts with mCRPC.
Clinical • P1 data • Metastases
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STEAP1 (STEAP Family Member 1)
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STEAP1 expression
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xaluritamig (AMG 509)
over1year
Interim results from a phase I study of AMG 509 (xaluritamig), a STEAP1 x CD3 XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2023)
Preliminary PK showed dose-proportional increase in exposure with a mean terminal half-life of approximately 3-4 days. Table: 1765O Lower DLs (DL 1–7) Higher DLs (DL8–15) Overall PSA evaluable N = 43 N = 46 N = 89 PSA ≥ 50%, n (%) 17 (39.5) 25 (54.3) 42 (47.2) PSA ≥ 90%, n (%) 8 (18.6) 16 (34.8) 24 (27.0) RECIST evaluable N = 30 N = 36 N = 66 PR, n (%) 1 (3.3) 14 (38.9) 15 (22.7) SD, n (%) 18 (60.0) 12 (33.3) 30 (45.5) Conclusions Xaluritamig was tolerable with low-grade CRS (occurring primarily cycle 1) with encouraging preliminary efficacy in heavily pretreated pts with mCRPC.
Clinical • P1 data • Metastases
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STEAP1 (STEAP Family Member 1)
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STEAP1 expression
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xaluritamig (AMG 509)
almost2years
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=464, Recruiting, Amgen | Trial completion date: Nov 2027 --> Jun 2028 | Trial primary completion date: Nov 2025 --> Jun 2026
Trial completion date • Trial primary completion date • Metastases
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STEAP1 (STEAP Family Member 1)
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docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • xaluritamig (AMG 509)
almost4years
[VIRTUAL] Phase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2021)
Key inclusion criteria: men ≥18 years with histologically/cytologically confirmed mCRPC who are refractory to novel hormonal therapy (e.g., abiraterone and/or enzalutamide) and have failed 1–2 taxane regimens or are medically unsuitable for or have refused taxanes; ongoing castration with total serum testosterone ≤50 ng/dL; evidence of progressive disease; ECOG performance status 0–1; life expectancy ≥3 months; and adequate hematologic, renal, hepatic, and cardiac function. Key exclusion criteria: pure small cell or neuroendocrine carcinoma of the prostate; untreated CNS metastases or leptomeningeal disease; any anticancer therapy or immunotherapy, radiation therapy, or major surgery <4 weeks from first dose; history of or current autoimmune disease or any disease requiring immunosuppressive therapy (≤10 mg/d prednisone permitted); prior STEAP1-targeted therapy; infection requiring IV antimicrobials <7 days from first dose. The study opened in January 2020 and is recruiting patients.
Clinical • P1 data • IO biomarker
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STEAP1 (STEAP Family Member 1)
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STEAP1 expression
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Xtandi (enzalutamide capsule) • abiraterone acetate • xaluritamig (AMG 509)
over4years
[VIRTUAL] Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2020)
Key inclusion criteria: men ≥18 years with histologically/cytologically confirmed mCRPC who are refractory to novel hormonal therapy (e.g., abiraterone and/or enzalutamide) and have failed 1–2 taxane regimens or are medically unsuitable for or have refused taxanes; ongoing castration with total serum testosterone ≤50 ng/dL; evidence of progressive disease; ECOG performance status 0–1; life expectancy ≥3 months; and adequate hematologic, renal, hepatic, and cardiac function...Key exclusion criteria: pure small-cell or neuroendocrine carcinoma of the prostate; untreated CNS metastases or leptomeningeal disease; any anticancer therapy or immunotherapy, radiation therapy, or major surgery <4 weeks from first dose; history of or current autoimmune disease or any disease requiring immunosuppressive therapy (≤10 mg/d prednisone permitted); prior STEAP1-targeted therapy; infection requiring IV antimicrobials <7 days from first dose. The study opened in January 2020 and is recruiting patients. Research Funding: Amgen Inc.
Clinical • P1 data • IO biomarker
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STEAP1 (STEAP Family Member 1) • KLK3 (Kallikrein-related peptidase 3)
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STEAP1 expression
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Xtandi (enzalutamide capsule) • abiraterone acetate • prednisone • xaluritamig (AMG 509)