Clinical trial NCT05867121: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Solid Tumor
Non-small Cell Lung Cancer
Gastric Cancer
Pancreatic Ductal Adenocarcinoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical Co.
First posted: 2023-05-19
Enrollment: 102
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: The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 3 months
* Adequate hematologic and end organ function
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment
* Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within 9 months after the final dose of oxaliplatin and within 6 months after the final dose of all other study treatment
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
* History of leptomeningeal disease
* Uncontrolled tumor-related pain
* Positive test for human immunodeficiency virus (HIV) infection
* Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening
* Positive hepatitis C virus (HCV) antibody test at screening
* Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 29 months
Secondary outcomes:
measure: Plasma Concentration of RO7496353
timeFrame: Up to approximately 29 months
measure: Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
timeFrame: Up to approximately 29 months
measure: Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 29 months
measure: Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
timeFrame: Up to approximately 29 months
measure: Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1
timeFrame: Up to approximately 29 months
Other outcomes:
measure: Cohort A and C: Serum Concentration of Atezolizumab
timeFrame: Up to approximately 29 months
measure: Cohort A and C: Percentage of Participants with ADA to Atezolizumab
timeFrame: Up to approximately 29 months
Locations:
city: Los Angeles
country: United States
facility: UCLA University of California Los Angeles
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos
state: São Paulo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
state: Lazio
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
state: Lombardia
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona
state: Veneto
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia -PPDS
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Pozuelo de Alarcon
country: Spain
facility: NEXT Oncology-Hospital Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Madrid
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Lzmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: