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=37 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Solid Tumor

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Amgen | N=220 ➔ 37 | Trial completion date: Feb 2028 ➔ Apr 2026 | Trial primary completion date: Jun 2027 ➔ Apr 2026 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CDH3 • MSLN

ZW171, a differentiated 2+1 T cell-engaging bispecific antibody with antitumor activity in a range of mesothelin-expressing cancers (AACR 2025) - P1 | "We previously showed that the unique geometry and 2+1 design of ZW171 facilitates tumor selective binding and potent preferential killing of MSLN-mid and -high target cells, while sparing MSLN-low expressing target cells, and enhanced antitumor activity compared to other 2+1 TCE formats and the clinical benchmark HPN536 in MSLN-expressing PBMC-engrafted CDX models. To address the evolving clinical landscape and assess antitumor activity in additional indications and more translationally relevant models, we assessed ZW171 activity in advanced patient-derived organoid and xenograft models and benchmarked to other MSLN-targeting TCE including AMG 305, JNJ-79032421 and CT95...Overall, ZW171 demonstrates differentiated and potent antitumor activity in a range of MSLN-expressing cancers. ZW171 is being evaluated in a Phase 1 clinical trial in MSLN-expressing solid tumors (NCT06523803)."

Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • MSLN

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Amgen | Trial completion date: Sep 2027 ➔ Feb 2028 | Trial primary completion date: Jan 2027 ➔ Jun 2027

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric 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: 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