Clinical trial NCT06031441: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 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: Locally Advanced Solid Tumors
Recurrent Solid Tumors
Metastatic Solid Tumors
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 250
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 I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life expectancy \>=3 months, in the investigator's judgment
* Adequate hematologic and end-organ function
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
* Measurable disease per RECIST v1.1
* Tumor specimen availability, for certain cohorts

Exclusion Criteria:

* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
* Active hepatitis B or C
* Active tuberculosis
* Positive test for HIV infection
* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation
* Uncontrolled tumor-related pain
* Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with DLTs
timeFrame: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
measure: Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
timeFrame: Up to approximately 39 months
Secondary outcomes:
measure: Area Under the Serum Concentration Time Curve (AUC) of RO7566802
timeFrame: Up to approximately 39 months
measure: Maximum Serum Concentration (Cmax) of RO7566802
timeFrame: Up to approximately 39 months
measure: Minimum Serum Concentration (Cmin) of RO7566802
timeFrame: Up to approximately 39 months
measure: Total Clearance (CL) of RO7566802
timeFrame: Up to approximately 39 months
measure: Volume of Distribution at Steady State (Vss) of RO7566802
timeFrame: Up to approximately 39 months
measure: Serum Concentration of Atezolizumab
timeFrame: Up to approximately 39 months
measure: Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
timeFrame: Up to approximately 39 months
measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802
timeFrame: From Baseline up to approximately 39 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (ISMMS)
state: New York
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - 600 10th Ave W
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Sutton
country: United Kingdom
facility: The Royal Marsden hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: