A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hoffmann-La Roche
Study ID
NCT05129280
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • RO7444973 — DRUG
    RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.
  • Tocilizumab — DRUG
    Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Study Details

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A\*02:01 allele.

Key Dates

Start date
Jan 25, 2022
Status verified
Aug 2023
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I: Single Participant Cohort (SPC) Dose Escalation
    In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.
  • Experimental: Part II: Multiple Participant Cohort (MPC) Dose Escalation
    In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.
  • Experimental: Part III: Recommended Phase 2 Dose (RP2D) Expansion
    Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From start of treatment up to 90 days after last RO7444973 dose (up to 15 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MA

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