Clinical trial NCT06537310: A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
Official title: An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cancer-Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged ≥18 years
* Body weight \> 40 kilograms (kg)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
* Participants with advanced and/or metastatic solid tumors
* Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
* Negative serum pregnancy test
* Participants must have adequate cardiovascular, hematological, liver and renal function.

Exclusion Criteria:

* Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
* Active second malignancy within 2 years prior to screening
* History or current clinically significant cardiovascular/cerebrovascular disease
* Active or history of autoimmune disease
* Serious, uncontrolled infection
* Known clinically significant liver disease
* Unresolved acute toxicity \> grade 1 from prior therapy

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
timeFrame: Up to a maximum of 27 months
measure: Percentage of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: From baseline to 3 weeks on study
Secondary outcomes:
measure: Maximum Concentration (Cmax) Derived for RO7567132
timeFrame: Up to a maximum of 24 months
measure: Time of Maximum Concentration (Tmax)
timeFrame: Up to a maximum of 24 months
measure: Minimum Concentration (Cmin)
timeFrame: Up to maximum of 24 Months
measure: Clearance (CL) or Apparent Clearance (CL/F)
timeFrame: Up to a maximum of 24 months
measure: Volume of Distribution at Steady State (Vss)
timeFrame: Up to a maximum of 24 months
measure: Area Under the Curve (AUC) for Various Time Intervals
timeFrame: Up to a maximum of 24 months
measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
timeFrame: Up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: Up to a maximum of 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to a maximum of 24 months
measure: Duration of Response (DoR)
timeFrame: Up to a maximum of 24 months
measure: Progression Free Survival (PFS)
timeFrame: Up to a maximum of 24 months
measure: Overall Survival (OS)
timeFrame: Up to a maximum of 24 months
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Kinghorn Cancer Centre
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Vancouver
country: Canada
facility: BC Cancer ? Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra Madrid
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical trails
role: STUDY_DIRECTOR
References: