Clinical trial NCT06488716: 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
Official title: A Phase Ia/Ib, Open-Label, Multicenter 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumour
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Number of Participants iwth Dose Limiting Toxicity (DLTs)
timeFrame: Up to approximately 5 years
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of RO7759065
timeFrame: Up to approximately 5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to Approximately 5 Years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 5 years
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Chattanooga
country: United States
facility: Tennesse Oncology - NASH - SCRI - PPDS
state: Tennessee
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine
state: Quebec
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Madrid
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
References: