A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

• Conditions: ocally Advanced or Metastatic Solid Tumors; A solid tumor/cancer is an abnormal tissue mass that arises from uncontrolled growth of cells and continues to grow locally or spread to other parts of the body (metastatic).; 10027476

• Registration Number: NL-OMON53546
• Lead Sponsor: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

- Age ><= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy ><= 12 weeks
- Adequate hematologic and end-organ function
- Histologically confirmed locally advanced, recurrent, or metastatic incurable
solid tumor malignancy
- Availability of representative tumor specimens
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST v1.1)
- For women of childbearing potential: agreement to remain abstinent (refrain
from heterosexual intercourse) or use contraception, and agreement to refrain
from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraception, and agreement to refrain from donating sperm

Exclusion Criteria

- Pregnant or breastfeeding, or intending to become pregnant during the study
or within 5 months after the final dose of study treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- History of leptomeningeal disease
- Significant cardiovascular disease within 3 months prior to initiation of
study treatment
- History of malignancy other than disease under study within 3 years prior to
screening
- Any immune-mediated adverse events related to prior cancer immunotherapy that
have not resolved completely to baseline
- Active or history of autoimmune disease or immune deficiency
- Active tuberculosis, hepatitis B or acute or chronic active EBV infection
- Positive test for human immunodeficiency virus (HIV) infection
- Positive hepatitis C virus (HCV) antibody test
- Known infection with severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2)
- Major surgical procedure or significant traumatic injury within 28 days prior
to first study drug infusion
- Prior allogeneic stem cell or organ transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety objective:<br /><br>The safety objective for this study is to evaluate the safety of RO7502175 when<br /><br>administered as a single agent (Phase Ia) or in combination with atezolizumab<br /><br>(Phase Ib), including characterization of dose-limiting toxicities (DLTs), on<br /><br>the basis of the following endpoints:<br /><br>* Incidence and nature of DLTs<br /><br>* Incidence and severity of adverse events, with severity determined according<br /><br>to National Cancer Institute Common Terminology Criteria for Adverse Events,<br /><br>Version 5.0 (NCI CTCAE v5.0)<br /><br>* Change from baseline in targeted vital signs<br /><br>* Change from baseline in targeted clinical laboratory test results<br /><br>* Change from baseline in ECG parameters</p><br>