A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04338685
Phase
PHASE1
Status
Completed

Conditions

  • Biliary Tract Cancer
  • Carcinoma, Hepatocellular
  • Liver Metastases
  • Secondary Liver Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7119929 — DRUG
    RO7119929 will be administered orally as a capsule
  • Tocilizumab — DRUG
    Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome. Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants \> 30 kg: 8 mg/kg, for participants \< 30 kg: 12mg/kg IV

Study Details

Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.

Key Dates

Start date
Jul 16, 2020
Status verified
Oct 2024
Primary completion
Jan 9, 2023
Completion
Jan 9, 2023

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1-1 mg RO7119929
    Participants received 1mg RO7119929 every week in 3-week cycles.
  • Experimental: Part A1-3 mg RO7119929
    Participants received 4 mg RO7119929 every week in 3-week cycles
  • Experimental: Part A1 - 6 mg RO7119929
    Participants received 6 mg RO7119929 every week in 3-week cycles
  • Experimental: Part A1 -9 mg RO7119929
    Participants received 9 mg RO7119929 every week in 3-week cycles
  • Experimental: Part B1-5 mg RO7119929
    Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
  • Experimental: Part A2- 2/5/5 mg RO7119929
    Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
  • Experimental: Part A2- 2/5/6 mg RO7119929
    Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
  • Experimental: Part A3-4 mg RO7119929
    Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLT) [ Time Frame: Baseline up to approximately 14 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-

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By research site
City of Hope Cancer Center· Duarte, CA

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