AZD8853 / AstraZeneca - LARVOL DELTA

Safety and efficacy of AZD8853, an anti-growth and differentiation factor 15 (GDF15) antibody, in patients (pts) with advanced/metastatic solid tumors: First-in-human study (AACR 2024) - P1/2 | "AZD8853 was well tolerated. No objective responses or PD effects were seen and GDF15 suppression was not sustained, therefore no further development is planned.Table. AZD8853 safety*Death due to serious AE of cardiac arrest, unrelated to AZD8853; pt had a history of coronary artery disease, coronary stenting, and pulmonary embolism.†One pt discontinued due to clinical progression prior to completing the DLT evaluation period and was not included in the DLT-evaluable set."

Clinical • First-in-human • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD4 • GDF15

First-in-human study to evaluate the safety and efficacy of anti-GDF15 antibody AZD8853 in patients with advanced/metastatic solid tumors. (PubMed, Cancer Res Commun) - P1/2 | "AZD8853 was well tolerated; however, no objective responses or pharmacodynamic effects were seen and GDF15 suppression was not sustained. The study was stopped after dose escalation."

Journal • P1 data • Cachexia • Colorectal Cancer • Oncology • Pain • Solid Tumor • Urothelial Cancer • GDF15

Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications. (PubMed, Chin Med J (Engl)) - "Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine."

Journal • Cachexia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor • GDF15

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=16 | Terminated | Sponsor: AstraZeneca | N=165 ➔ 16 | Trial completion date: Jun 2024 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jun 2023; This study was terminated in accordance to protocol Section 4.4, based on the overall risk-benefit profile observed to date.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Bladder Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

First-in-human study of AZD8853, an anti-growth and differentiation factor 15 (GDF15) antibody, in patients (pts) with advanced/metastatic solid tumors (AACR 2023) - "Abstract is embargoed at this time."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • GDF15

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=165 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=165 | Not yet recruiting | Sponsor: AstraZeneca

New P1/2 trial • Bladder Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • GDF15

[VIRTUAL] AZD8853: A novel antibody targeting GDF15 for immunotherapy refractory tumors (AACR 2021) - "Depletion of T cells, using anti-CD4 and anti-CD8, in mice ablates the anti-tumor activity observed with anti-GDF15 mAb treatment. These results suggest that inhibition of GDF15 by AZD8853 may be an attractive therapeutic strategy for patients with solid tumors that have high expression of GDF15."

IO biomarker • Oncology • Solid Tumor • CD8 • GDF15 • TGFB1

AstraZeneca accelerates early oncology pipeline across key strategic scientific platforms at AACR (AstraZeneca Press Release) - P1/2, N=55; ATRiUM (NCT03669601); "AstraZeneca will share updates from the Company’s innovative early oncology pipeline across multiple strategic platforms during the virtual American Association of Cancer Research (AACR) Annual Meeting, 10 to 15 April 2021...Five presentations will unveil the next-generation PARP1 selective inhibitor AZD5305...Data for AZD5305 will demonstrate how the next wave of DNA damage response medicines can build on the success of PARP inhibitors, potentially allowing patients to stay on treatment longer."

Clinical data • P1 data • P2 data • Preclinical • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colon Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology