A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Sponsor
Hoffmann-La Roche
Study ID
NCT04303858
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Eciskafusp Alfa — DRUG
    Participants will be administered eciskafusp alfa in different schedules.
  • Atezolizumab — DRUG
    Participants will be administered 1200 mg of atezolizumab once every 3 weeks.

Study Details

This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

Key Dates

Start date
May 4, 2020
Status verified
May 2026
Primary completion
Oct 2, 2025
Completion
Oct 2, 2025

Study Design

Enrollment
189 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eciskafusp Alfa as a Single Agent
    Part 1: Dose-escalation of eciskafusp alfa as a single agent. eciskafusp alfa will be either an intravenous administration (IV) or subcutaneous administration (SC) in multiple-ascending doses.
  • Experimental: Eciskafusp Alfa in Combination with Atezolizumab
    Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab.
  • Experimental: Eciskafusp Alfa as a Single Agent and/or with Atezolizumab
    Part 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab.

Primary Outcome Measure

Percentage of Participants with Adverse Events in Part 1 and Part 2 [ Time Frame: From randomization until end of Part 1 and Part 2 (up to approximately 1.5 months) ]

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