enzelkitug (RG6411) / Roche - LARVOL DELTA

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=165 | Active, not recruiting | Sponsor: Genentech, Inc. | Recruiting ➔ Active, not recruiting | N=450 ➔ 165

Checkpoint inhibition • Enrollment change • Enrollment closed • First-in-human • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=450 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Feb 2027 ➔ Jul 2028 | Trial primary completion date: Feb 2027 ➔ Jul 2028

Checkpoint inhibition • First-in-human • Trial completion date • Trial primary completion date • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=450 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Aug 2026 ➔ Feb 2027 | Trial primary completion date: Aug 2026 ➔ Feb 2027

Checkpoint inhibition • Trial completion date • Trial primary completion date • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=450 | Recruiting | Sponsor: Genentech, Inc. | Trial primary completion date: Apr 2026 ➔ Aug 2026

Checkpoint inhibition • Trial primary completion date • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=395 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Oct 2025 ➔ Aug 2026 | Trial primary completion date: Jul 2025 ➔ Apr 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Preclinical and translational pharmacology of afucosylated anti-CCR8 antibody for depletion of tumour-infiltrating regulatory T cells. (PubMed, Br J Pharmacol) - "This work demonstrates a translational research strategy for collecting and utilizing relevant nonclinical data, developing a mechanistic PK/PD model and using a comprehensive approach to inform clinical study design for RO7502175."

Journal • Preclinical • Oncology • Solid Tumor • CCR8

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=365 | Recruiting | Sponsor: Genentech, Inc. | Phase classification: P1a/1b ➔ P1

Combination therapy • Metastases • Phase classification • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

"And 6 new projects in the clinic for $RHHBY, incl 2 undisclosed mechanisms in oncology: RG6524 (=RO7616789) FPI Jan 2023 https://t.co/qNRZpOUvjW RG6411 (=RO7502175) FPI Q4 2022 https://t.co/p48EaRVy85" (,@JacobPlieth)

Oncology

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1a/1b | N=365 | Recruiting | Sponsor: Genentech, Inc.

Combination therapy • New P1 trial • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer