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- || tarlatamab (AMG 757) / Amgen, AMG 119 / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie
Review, Journal: Delta-like ligand 3 in small cell lung cancer: potential mechanism and treatment progress. (Pubmed Central) - Sep 16, 2023
However, other drugs that target DLL3, such as AMG119, AMG757 and DLL3-targeted NIR-PIT, bring new ideas for SCLC treatment. Overall, DLL3 remains a valuable target for SCLC.
- AMG 119 / Amgen
Trial completion date, Trial primary completion date: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Sep 15, 2023
P1, N=6, Suspended, Sponsor: Amgen
Overall, DLL3 remains a valuable target for SCLC. Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
- | AMG 119 / Amgen
Journal, CAR T-Cell Therapy: Clinical Pharmacology Profile of AMG 119, the First Chimeric Antigen Receptor T (CAR-T) Cell Therapy Targeting Delta-like ligand 3 (DLL3), in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC). (Pubmed Central) - Sep 11, 2023
AMG 119 has been clinically safe and well tolerated at the doses tested with no dose-limiting toxicities (DLTs) reported. This is the first publication of the clinical pharmacology profile of a CAR-T cell therapy in SCLC, with encouraging cellular kinetics data supporting the potential for CAR-T cell therapy in solid tumor space.
- tarlatamab (AMG 757) / Amgen, AMG 119 / Amgen
Subtype-specific targeting of cell surfaceome with CAR T therapies in small cell lung cancer (Section 37; Poster Board #16) - Mar 14, 2023 - Abstract #AACR2023AACR_4650;
This study demonstrated efficacy of CAR Ts targeting several cell surfaceome targets enriched in certain subtypes of SCLC. The data supports further investigation of a subtype-specific personalized treatment of SCLC using CAR T therapies against surfaceome targets.
- | AMG 119 / Amgen
Journal, Cancer stem cells: Targeting cancer stem cell pathways for lung cancer therapy. (Pubmed Central) - Dec 8, 2022
The current review elucidates the characteristics and related regulating pathways of lung CSCs from essential to preclinical research. We retrospectively introduce an update on the clinical development of therapeutics targeting CSC-associated developmental signaling pathways and discuss the opportunities to target CSC-immune interactions in lung cancer.
- ||| AMG 119 / Amgen
Clinical, FDA event: Any ideas why the AMG 119 study was suspended, and 20 months later remains on clinical hold? $AMGN #SITC22 (Twitter) - Nov 11, 2022
- |||||| AMG 119 / Amgen
Clinical, CAR T-Cell Therapy: At #SITC22, Dr. Lauren Byers is presenting abstract 697, which shows AMG 119, the first CAR T cell therapy for small cell lung cancer, has a manageable safety profile and promising anti-tumor activity. Read the Phase I results: https://t.co/olOJn1NJc9 @LaurenByersMD #EndCancer (Twitter) - Nov 10, 2022
- AMG 119 / Amgen
A phase 1 study of AMG 119, a DLL3-targeting, chimeric antigen receptor (CAR) T cell therapy, in relapsed/refractory small cell lung cancer (SCLC) (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1015;
Conclusions AMG 119 , the first CAR-T cell therapy for SCLC, was associated with a manageable safety profile and promising anti-tumor activity. Enrollment is currently paused but may resume.
- AMG 119 / Amgen
Trial completion date, Trial primary completion date: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Nov 30, 2021
P1, N=6, Suspended, Sponsor: Amgen
Enrollment is currently paused but may resume. Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026
- ||| AMG 119 / Amgen
Trial suspension: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Mar 23, 2021
P1, N=6, Suspended, Sponsor: Amgen
Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026 Active, not recruiting --> Suspended
- | nirogacestat (PF-03084014) / SpringWorks Therap
Journal: Precision medicine for human cancers with Notch signaling dysregulation (Review). (Pubmed Central) - Sep 13, 2020
Small‑molecule γ‑secretase inhibitors (AL101, MRK‑560, nirogacestat and others) and antibody‑based biologics targeting Notch ligands or receptors [ABT‑165, AMG 119, rovalpituzumab tesirine (Rova‑T) and others] have been developed as investigational drugs...Phase III clinical trials of Rova‑T for patients with small‑cell lung cancer and a phase III clinical trial of nirogacestat for patients with desmoid tumors are ongoing. Integration of human intelligence, cognitive computing and explainable artificial intelligence is necessary to construct a Notch‑related knowledge‑base and optimize Notch‑targeted therapy for patients with cancer.
- | AMG 757 / Amgen, AMG 119 / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie, BMS
Review, Journal: DLL3: an emerging target in small cell lung cancer. (Pubmed Central) - Jun 18, 2020
It is therefore being explored as a potential therapeutic target in SCLC. Here, we review the preclinical and clinical evidence for targeting DLL3 in SCLC and discuss several DLL3-specific therapies being developed for the treatment of SCLC: the antibody-drug conjugate rovalpituzumab tesirine, the bispecific T cell engager immuno-oncology therapy AMG 757, and the chimeric antigen receptor T cell therapy AMG 119.
- AMG 757 / Amgen, AMG 119 / Amgen
AMG 757 (DLL3) + AMG 119 (DLL3) (CAR-T) (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_90;
- | AMG 119 / Amgen
Trial completion date, Trial primary completion date: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Feb 17, 2020
P1, N=6, Active, not recruiting, Sponsor: Amgen
Here, we review the preclinical and clinical evidence for targeting DLL3 in SCLC and discuss several DLL3-specific therapies being developed for the treatment of SCLC: the antibody-drug conjugate rovalpituzumab tesirine, the bispecific T cell engager immuno-oncology therapy AMG 757, and the chimeric antigen receptor T cell therapy AMG 119. Trial completion date: Mar 2020 --> Jan 2025 | Trial primary completion date: Mar 2020 --> Jan 2025
- | AMG 119 / Amgen
Trial completion date, Trial primary completion date: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Nov 21, 2019
P1, N=6, Active, not recruiting, Sponsor: Amgen
Trial completion date: Mar 2020 --> Jan 2025 | Trial primary completion date: Mar 2020 --> Jan 2025 Trial completion date: Jun 2021 --> Mar 2020 | Trial primary completion date: Jun 2021 --> Mar 2020
- | AMG 119 / Amgen
Enrollment closed, Enrollment change: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Jul 11, 2019
P1, N=6, Active, not recruiting, Sponsor: Amgen
Trial completion date: Jun 2021 --> Mar 2020 | Trial primary completion date: Jun 2021 --> Mar 2020 Recruiting --> Active, not recruiting | N=41 --> 6
- | AMG 119 / Amgen
Trial completion date, Trial primary completion date: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Jun 25, 2019
P1, N=41, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting | N=41 --> 6 Trial completion date: Aug 2020 --> Jun 2021 | Trial primary completion date: Aug 2020 --> Jun 2021
- || AMG 119 / Amgen
Enrollment open: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Jun 15, 2018
P1, N=41, Recruiting, Sponsor: Amgen
Trial completion date: Aug 2020 --> Jun 2021 | Trial primary completion date: Aug 2020 --> Jun 2021 Not yet recruiting --> Recruiting
- | AMG 119 / Amgen
New P1 trial: A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC (clinicaltrials.gov) - Jan 5, 2018
P1, N=41, Not yet recruiting, Sponsor: Amgen