AMG 794 / Amgen - LARVOL DELTA

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Amgen | Trial completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Breast Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Amgen | N=98 ➔ 3 | Trial completion date: Feb 2028 ➔ Dec 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2026 ➔ Dec 2023; Amgen has made the business decision to discontinue development of AMG 794. The safety profile of AMG 794 remains unchanged.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Amgen | Active, not recruiting ➔ Recruiting | Trial completion date: Jun 2027 ➔ Feb 2028 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Amgen | Trial completion date: Nov 2027 ➔ Feb 2027 | Trial primary completion date: May 2026 ➔ Aug 2025

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Amgen | Trial completion date: Jun 2027 ➔ Nov 2027 | Trial primary completion date: Dec 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Germ Cell Tumors • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • Triple Negative Breast Cancer • CLDN6

A Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer. (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Amgen | Trial completion date: May 2026 ➔ Jun 2027 | Initiation date: May 2022 ➔ Oct 2022 | Trial primary completion date: Jul 2024 ➔ Dec 2025

Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

AMG 794, a Claudin 6-targeted half-life extended (HLE) bispecific T cell engager (BITE®) molecule for non-small cell lung cancer and epithelial ovarian cancer (AACR 2022) - "The potent, selective activity of AMG 794 for CLDN6-expressing NSCLC and EOC cells, together with an acceptable nonclinical safety profile, supported the advancement of AMG 794 into clinical development. A first-in-human study to explore the safety, tolerability, pharmacokinetics, and anti-tumor activity of AMG 794 in patients with CLDN6-positive advanced / metastatic non-squamous NSCLC or EOC will be enrolling patients in March 2022."

Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • CLDN6

A Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer. (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Amgen

New P1 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

AMGEN TO PRESENT LONG-TERM OUTCOMES FOR LUMAKRAS (SOTORASIB) IN KRAS G12C-MUTATED NSCLC AT AACR 2022 (PRNewswire) - "Late-Breaking Oral Presentation Includes Two-Year Follow-Up Data from CodeBreaK 100 Study - the Most Advanced KRAS G12C Clinical Dataset; Pre-Clinical Data Evaluating Half-Life Extended BiTE® Molecule AMG 794 Targeting CLDN6 to be Presented for the First Time...Amgen...announced that new data from across its oncology portfolio and pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting from April 8-13 in New Orleans, Louisiana."

Late-breaking abstract • P1/2 data • Preclinical • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer