GO43860

A phase Ia/Ib, Open Label, Multicenter, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

  • Code NKI: M22GIR
  • Code firma: GO43860
  • Code clinicaltrials.gov: NCT05581004

Principal Investigator

Dr. N. Steeghs

Drugs

RO7502175 (anti-CCR8 antibody) + atezolizumab

  • Expansion cohort A for melanoma PDL1+ – open
  • Expansion cohort A for PDL-1+ NSCLC – closed
  • Expansion cohort A for HNSCC – open
  • Expansion cohort B for PDL1+ RCC – open
  • Expansion cohort B for PDL-1+ NSCLC – open
  • Expansion cohort B for melanoma (no PDL1 cutoff) – open
  • expansion cohort B for RCC (no PDL1 cutoff) – open
  • Expansion serial biopsy cohort for all tumor types – open

Summary

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with Atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Read more on clinicaltrials.gov

Patient population

Tumor type: Melanoma / NSCLC, lung cancer, non small cell lung cancer / Head and Neck Squamous Carcinoma, HNSCC  / Breast cancer, breast carcinoma / Urothelial cancer, bladder cancer / Esophageal cancer, esophagus carcinoma / Stomach cancer, gastric cancer / Cervical cancer, Cervical Carcinoma, Cervix carcinoma / Hepatocellular carcinoma, HCC / Breast cancer, breast carcinoma
Tumor subtype: TNBC, triple negative breast cancer