Clinical trial NCT05581004: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Official title: 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 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
NSCLC
HNSCC
Melanoma
TNBC
Esophageal Cancer
Gastric Cancer
Cervical Cancer
Colorectal Cancer
Urothelial Carcinoma
Clear Cell RCC
HCC
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 450
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 study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.


Eligibility criteria: Inclusion Criteria:

* Life expectancy at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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
* Tumor Specimen availability

Exclusion Criteria:

* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, 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 RO7502175 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation

Primary outcomes:
measure: Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
measure: Phase Ib: Number of Participants with DLTs
timeFrame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)
measure: Phase Ia: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Up to approximately 5 years
measure: Phase Ib: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175
timeFrame: From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)
measure: Phase Ia and Phase Ib: Objective Response Rate (ORR)
timeFrame: From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
measure: Phase Ia and Phase Ib: Duration of Response (DOR)
timeFrame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
measure: Phase Ia and Phase Ib: Progression Free Survival (PFS)
timeFrame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)
measure: Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175
timeFrame: From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarasota
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University Medical Center, Division of Oncology
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Germantown
country: United States
facility: The West Clinic - Memphis (Union Ave)
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
city: Darlinghurst
country: Australia
facility: Kinghorn Cancer Centre
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health Monash Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Herstal
country: Belgium
facility: CHU de Liège
city: Wilrijk
country: Belgium
facility: GasthuisZusters Antwerpen
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital
state: Quebec
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
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: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: L?Hospitalet De Llobregat
country: Spain
facility: ICO l?Hospitalet ? Hospital Duran i Reynals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: START MADRID_Hospital Universiario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: