RECRUITING

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

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.

Conditions

Cancer-Neoplasms
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Related Conditions:

Cancer-Neoplasms

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cancer-Neoplasms
Intervention / Treatment

-

Contacts and Locations

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female participants aged ≥18 years
  • * Body weight \> 40 kilograms (kg)
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
  • * Participants with advanced and/or metastatic solid tumors
  • * Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
  • * Negative serum pregnancy test
  • * Participants must have adequate cardiovascular, hematological, liver and renal function.
  • * Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
  • * Active second malignancy within 2 years prior to screening
  • * History or current clinically significant cardiovascular/cerebrovascular disease
  • * Active or history of autoimmune disease
  • * Serious, uncontrolled infection
  • * Known clinically significant liver disease
  • * Unresolved acute toxicity \> grade 1 from prior therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical trails, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2029-06-19