AMG 305 / Amgen - LARVOL DELTA

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=260 | Recruiting | Sponsor: Amgen | Trial completion date: Jan 2027 ➔ Aug 2027 | Trial primary completion date: May 2026 ➔ Dec 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH3 • MSLN

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=260 | Recruiting | Sponsor: Amgen | Trial completion date: Oct 2026 ➔ Jan 2027 | Trial primary completion date: Feb 2026 ➔ May 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH3 • MSLN

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=260 | Recruiting | Sponsor: Amgen | Trial primary completion date: Apr 2025 ➔ Feb 2026

Metastases • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH3 • MSLN

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=260 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2026 ➔ Apr 2025

Enrollment open • Metastases • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH3 • MSLN

AMG 305, a dual targeting BiTE®molecule with selective activity for solid tumors that co-express CDH3 and MSLN (AACR 2023) - "AMG 305 was clinically well-tolerated in a nonclinical safety study in cynomolgus monkey. Data from IND-enabling preclinical studies support initiation of the first-in-human study of AMG 305 in CDH3+MSLN+ solid tumors in 2023."

Oncology • Solid Tumor • CDH3 • MSLN

"Next up at #AACR23 New Drugs on the Horizon pt 2, Amgen discloses AMG305, a bispecific BiTE targeting CDH3 and MSLN." (@KRHornberger)

Oncology • CDH3 • MSLN

Phase 1 First-In-Human Study to Explore AMG 305 (clinicaltrials.gov) - P1 | N=260 | Not yet recruiting | Sponsor: Amgen

Metastases • New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDH3 • MSLN