- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Pembrolizumab in mCRPC - Combination therapies as breakthrough to success? (Pubmed Central) - Aug 21, 2023 This decision is not related to safety. ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC.
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Trial completion, Trial completion date, Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - Jul 12, 2023 P1, N=212, Completed, ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC. Active, not recruiting --> Completed | Trial completion date: May 2025 --> Jul 2023 | Trial primary completion date: May 2025 --> Jul 2023
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 22, 2022 P1b, N=3, Terminated, Trial completion date: Jul 2025 --> Nov 2023 N=50 --> 3 | Trial completion date: Jun 2026 --> Jan 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Dec 2021; Amgen made a business decision to discontinue AMG 160 20180273
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Enrollment closed: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jun 23, 2022 P1b, N=50, Active, not recruiting, N=50 --> 3 | Trial completion date: Jun 2026 --> Jan 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Dec 2021; Amgen made a business decision to discontinue AMG 160 20180273 Recruiting --> Active, not recruiting
- |||||||||| zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
Enrollment closed, Metastases: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Jun 22, 2022 P1/2, N=136, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Enrollment closed, Metastases: Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - Jun 6, 2022 P1, N=288, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
Enrollment closed, Metastases: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Jun 2, 2022 P1/2, N=159, Active, not recruiting, Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Trial primary completion date: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 19, 2022 P1b, N=50, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Feb 2026 --> Jun 2026
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - Mar 4, 2022 P1, N=288, Recruiting, These data support the ongoing clinical evaluation of AMG 160 in patients with mCRPC. Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025
- |||||||||| acapatamab (AMG 160) / Amgen
Journal: BiTE-ing into prostate cancer with bispecific T cell engagers. (Pubmed Central) - Jan 1, 2022 Targeting prostate-specific membrane antigen (PSMA) has important therapeutic ramifications, more recently including immune oncology. Data were recently presented on the preclinical efficacy of a half-life extended bispecific T cell engager, AMG 160, which binds PSMA and CD3 to induce T cell-driven cytolytic activity against prostate cancer.
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - Oct 4, 2021 P1, N=288, Recruiting, Data were recently presented on the preclinical efficacy of a half-life extended bispecific T cell engager, AMG 160, which binds PSMA and CD3 to induce T cell-driven cytolytic activity against prostate cancer. Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Enrollment open: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 30, 2021 P1b, N=50, Recruiting, Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025 Not yet recruiting --> Recruiting
- |||||||||| acapatamab (AMG 160) / Amgen
[VIRTUAL] Targeting the Tumor Neovasculature in Lung Cancer: A Phase I Study of AMG 160 in Subjects With Non - Small Cell Lung Cancer (ePoster Hall) - Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1103; P1 Detectable PSMA expression by 68Gallium-PSMA-11 PET/CT imaging, and an ECOG score of 0–2 are additional key inclusion criteria. Key exclusion criteria: presence of symptomatic brain metastases, active autoimmune disease, diseases requiring chronic systemic corticosteroid or immunosuppressive therapy.The study will enroll 10 patients with R/R non-squamous NSCLC in the dose exploration phase and ≥40 patients with R/R squamous and non-squamous NSCLC in the dose expansion phase across sites in the US, Australia, and Europe.
- |||||||||| zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Metastases: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Jul 1, 2021 P1, N=105, Recruiting, Key exclusion criteria: presence of symptomatic brain metastases, active autoimmune disease, diseases requiring chronic systemic corticosteroid or immunosuppressive therapy.The study will enroll 10 patients with R/R non-squamous NSCLC in the dose exploration phase and ≥40 patients with R/R squamous and non-squamous NSCLC in the dose expansion phase across sites in the US, Australia, and Europe. Trial completion date: Sep 2025 --> May 2025
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - Jun 7, 2021 P1, N=288, Recruiting, Trial completion date: Sep 2025 --> May 2025 Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2025 --> Apr 2025
- |||||||||| zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - Jun 3, 2021 P1, N=105, Recruiting, Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2025 --> Apr 2025 Trial completion date: Sep 2026 --> Sep 2025 | Trial primary completion date: Jan 2025 --> Apr 2025
- |||||||||| AMG 160 / Amgen
[VIRTUAL] Safety and efficacy of AMG 160, a half-life extended BiTE immune therapy targeting prostate-specific membrane antigen (PSMA), and other therapies for metastatic castration-resistant prostate cancer (mCRPC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2834; P1 Therapeutic combinations include AMG 160 + enzalutamide (A), AMG 160 + abiraterone (B), and AMG 160 + AMG 404 vs AMG 404 monotherapy (C)...Evaluation of preliminary antitumor activity will be based on RECIST 1.1 with Prostate Cancer Working Group 3 modifications, prostate-specific antigen (PSA) response, circulating tumor cell response, progression-free survival (radiographic, PSA, clinical), overall survival, and 68Ga-PSMA-11 and 18F-FDG PET/CT imaging . The study is currently recruiting patients.
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