Study of RO7515629 in Participants With HLA-G Positive Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT05769959
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • RO7515629 — DRUG
    RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
  • tocilizumab — DRUG
    Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Study Details

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G).

Key Dates

Start date
Jun 15, 2023
Status verified
Jul 2024
Primary completion
Mar 19, 2024
Completion
Mar 19, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I Single Participant Cohort RO7515629 Dose Escalation
    Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
  • Experimental: Part II Multiple Participant Cohort RO7515629 Dose Escalation
    Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
  • Experimental: Part III Multiple Participant Cohort RO7515629 Dose Expansion
    Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Primary Outcome Measure

Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 15 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
SCRI Oncology PartnersNashvilleTennessee37203-

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By research site
Sarah Cannon Research Institute at HealthONE· Denver, COSCRI Oncology Partners· Nashville, TN

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