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Trial Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06488716
Condition:
Solid Tumour
Conditions: Official terms:
Neoplasms
Atezolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7759065
Description:
Specified dose on specified days
Arm group label:
Phase Ia: Dose Escalation
Arm group label:
Phase Ia: Expansion
Arm group label:
Phase Ib: Dose Escalation
Arm group label:
Phase Ib: Expansion
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Specified dose on specified days
Arm group label:
Phase Ib: Dose Escalation
Arm group label:
Phase Ib: Expansion
Summary:
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose
expansion study designed to evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a
single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with
locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several
key aspects of the study design and study population are summarized below.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end-organ function
- Measurable disease according to Response Evaluation criteria in Solid Tumors
(RECIST) Version 1.1
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid
tumor malignancy
- Availability of representative tumor specimens required for patients in select
cohorts.
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Any anti-cancer therapy, whether investigational or approved, including
chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to
initiation of study treatment
- Active hepatitis B or C or tuberculosis
- Positive test for human immunodeficiency virus (HIV) infection
- Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before
first RO7759065 infusion
- Primary, untreated, or active central nervous system (CNS) metastases
- Active or history of autoimmune disease or immune deficiency
- Prior allogeneic stem cell or organ transplantation
- Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer
immunotherapy that resulted in permanent discontinuation of that agent
- Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer
immunotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Start date:
October 31, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06488716
