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- || AMG 340 / Amgen
Trial completion, Trial completion date, Trial primary completion date, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - Aug 9, 2024
P1, N=42, Completed, Sponsor: Amgen
Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2024 | Trial primary completion date: Sep 2024 --> Jun 2024
- || AMG 340 / Amgen
Enrollment change, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - May 1, 2024
P1, N=42, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2024 | Trial primary completion date: Sep 2024 --> Jun 2024 N=100 --> 42
- AMG 340 / Amgen
Phase 1 clinical trial of AMG 340, a prostate-specific membrane antigen (PSMA)-targeted T-cell engager with a novel low-affinity CD3 binding domain designed to mitigate toxicity for the treatment of metastatic castration-resistant prostate cancer (mCRPC). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6362;
P1
However, AMG 340 demonstrated manageable CRS toxicity showing that decreased CD3-binding strength mitigates CRS, the main toxicity of TCEs. Clinical studies are ongoing evaluating the PSMA protein as a molecular target for prostate cancer.
- || AMG 340 / Amgen
Enrollment closed, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - Nov 7, 2023
P1, N=100, Active, not recruiting, Sponsor: Amgen
Clinical studies are ongoing evaluating the PSMA protein as a molecular target for prostate cancer. Recruiting --> Active, not recruiting
- || AMG 340 / Amgen
Enrollment change, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - Jul 18, 2022
P1, N=130, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting N=72 --> 130
- || AMG 340 / Amgen
Trial completion date, Trial primary completion date, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - Feb 2, 2022
P1, N=72, Recruiting, Sponsor: Amgen
N=72 --> 130 Trial completion date: Mar 2023 --> Sep 2024 | Trial primary completion date: Mar 2022 --> Sep 2024
- | AMG 340 / Amgen
Journal: Attenuating CD3 affinity in a PSMAxCD3 bispecific antibody enables killing of prostate tumor cells with reduced cytokine release. (Pubmed Central) - Dec 22, 2021
Trial completion date: Mar 2023 --> Sep 2024 | Trial primary completion date: Mar 2022 --> Sep 2024 Our data suggest that TNB-585, with its low-affinity anti-CD3, may be efficacious while inducing a lower incidence and severity of CRS in patients with prostate cancer compared with TCEs that incorporate high-affinity anti-CD3 domains.
- ||| AMG 340 / Amgen
Enrollment open, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - May 17, 2021
P1, N=72, Recruiting, Sponsor: Teneobio, Inc.
Our data suggest that TNB-585, with its low-affinity anti-CD3, may be efficacious while inducing a lower incidence and severity of CRS in patients with prostate cancer compared with TCEs that incorporate high-affinity anti-CD3 domains. Not yet recruiting --> Recruiting
- TNB-585 / TeneoBio
[VIRTUAL] TNB585.001: A multicenter, phase 1, open-label, dose-escalation and expansion study of tnb-585, a bispecific T-cell engager targeting PSMA in subjects with metastatic castrate resistant prostate cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2838;
P1
The activity endpoints (per PCWG3/RECIST1.1) include overall response rate, PSA50, PSA30, CTC counts, progression free survival and overall survival . The relationship between PSMA expression (via PSMA-PET) and activity will be assessed.
- ||| AMG 340 / Amgen
New P1 trial, Metastases: TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - Feb 4, 2021
P1, N=72, Not yet recruiting, Sponsor: Teneobio, Inc.
- TNB-585 / TeneoBio
[VIRTUAL] TNB-585: A CD3xPSMA Bispecific Antibody for T-Cell Mediated Killing of Prostate Tumor Cells with Minimal Cytokine Release () - Oct 25, 2020 - Abstract #PCF2020PCF_1;
Overall, our data suggest that TNB-585 may be efficacious whilst inducing a lower incidence and severity of cytokine release syndrome in prostate cancer patients compared to currently available bispecific antibodies that utilize strong binding/activating anti-CD3 domains. Funding Acknowledgments: Partially funded by NCI grant #1R43CA232972-01
- TNB-585 / TeneoBio
[VIRTUAL] Effect of modulation of CD3 binding in a PSMAxCD3 T-cell engaging bispecific antibody on maintenance of efficient tumor cell kill and cytokine release. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_4481;
This molecule may improve safety, efficacy, and offer opportunities for combination therapy to treat CRPC. A Phase 1 clinical trial of this compound in CRPC is scheduled to begin in Q1 2021.