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ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: 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

Title
Genentech GO43860 Phase I broad
Study Title

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

Site Link
Malignancy
Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
>1st line
Investigational Agent
RO7502175
Drug Class
Anti-CCR8 antibody
PI
Dan Vaena, MD
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
  • Must have tumor specimen available
  • Measurable disease
  • ECOG PS 0-1
  • Life expectancy at least 12 weeks
  • Phase 1a- must have exhausted all standard therapies for their disease
  • Phase 1b- must have disease that has progressed after at least one available standard therapy
  • Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
  • No active HBV/HCV or chronic or acute EBV
  • No history of autoimmune disease
  • No symptomatic or actively progressing CNS mets
Objective
  • Primary
    • DLT
    • TEAE
  • Secondary
    • PK
    • ORR
    • DoR
    • PFS
    • Anti-drug antibody
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X