RECRUITING

A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

Official Title

An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Quick Facts

Study Start:2024-09-16
Study Completion:2029-06-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06537310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female participants aged ≥18 years
  2. * Body weight \> 40 kilograms (kg)
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
  4. * Participants with advanced and/or metastatic solid tumors
  5. * Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
  6. * Negative serum pregnancy test
  7. * Participants must have adequate cardiovascular, hematological, liver and renal function.
  1. * Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
  2. * Active second malignancy within 2 years prior to screening
  3. * History or current clinically significant cardiovascular/cerebrovascular disease
  4. * Active or history of autoimmune disease
  5. * Serious, uncontrolled infection
  6. * Known clinically significant liver disease
  7. * Unresolved acute toxicity \> grade 1 from prior therapy

Contacts and Locations

Study Contact

Reference Study ID Number: BP44956 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical trails
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

SCRI Oncology Partners
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical trails, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2029-06-19

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2029-06-19

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer-Neoplasms