ABBV-CLS-579 / AbbVie, Calico Life Sciences - LARVOL DELTA

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov) - P1 | N=101 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: May 2026 ➔ Aug 2025 | Trial primary completion date: May 2026 ➔ Aug 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov) - P1 | N=101 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=263 ➔ 101 | Trial primary completion date: Aug 2025 ➔ May 2026

Enrollment change • Enrollment closed • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov) - P1 | N=263 | Recruiting | Sponsor: Calico Life Sciences LLC | Trial completion date: Sep 2023 ➔ Apr 2026 | Trial primary completion date: Sep 2023 ➔ Aug 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1

First-in-human phase 1 studies of PTPN2/1 inhibitors ABBV-CLS-484 and ABBV-CLS-579 in locally advanced or metastatic tumors (AACR 2023) - P1 | "Preclinical data also indicated that PTPN2/1 inhibitors have improved efficacy when combined with PD-1-targeting agents (eg, pembrolizumab) or vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) in multiple tumor models. Evaluation of objective response rate (RECIST v1.1) is a primary objective in EXP phase and a secondary objective in ESC phase. Both studies are active, and as of 30 Nov 2022, 30 (ABBV-CLS-484) and 45 (ABBV-CLS-579) patients had been enrolled in ESC phase."

Metastases • P1 data • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IFNG • MSI • PTPN2

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov) - P1 | N=263 | Recruiting | Sponsor: Calico Life Sciences LLC | N=43 ➔ 263

Enrollment change • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI • PD-L1