AMG 355 / Amgen - LARVOL DELTA

Initial results of a phase 1 study of AMG 355, a novel anti-CCR8 antibody as a single agent and in combination with pembrolizumab in patients with solid tumors (AACR 2026) - "AMG 355 was safe and tolerable at doses up to 700 mg, but clinical activity as a single agent or combined with pembrolizumab was limited. Pharmacodynamic activity was observed, and further examination of the immune contexture is underway using digital pathology approaches."

Clinical • Combination therapy • First-in-human • P1 data • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCR8

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

First-in-human • Monotherapy • Trial completion • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

20220028: Phase 1 First in Human Study to Explore AMG 355 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (clinicaltrialsregister.eu) - P1 | N=135 | Active, not recruiting | Sponsor: Amgen Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Monotherapy • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Mar 2028 ➔ Aug 2026 | Trial primary completion date: Mar 2027 ➔ May 2026

First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=535 ➔ 77

Enrollment change • Enrollment closed • First-in-human • Monotherapy • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=535 | Recruiting | Sponsor: Amgen | Trial completion date: Dec 2028 ➔ Mar 2028 | Trial primary completion date: Mar 2028 ➔ Mar 2027

First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=535 | Recruiting | Sponsor: Amgen | Trial completion date: Feb 2028 ➔ Jan 2029 | Trial primary completion date: Feb 2027 ➔ Mar 2028

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=515 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor