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Trial Title:
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
NCT ID:
NCT06537310
Condition:
Cancer-Neoplasms
Conditions: Official terms:
Atezolizumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7567132 and Atezolizumab
Description:
RO7567132 will be administered either as monotherapy or in combination with atezolizumab
at a dose and schedule as specified for the respective cohort.
Arm group label:
Part I: RO7567132 Dose Escalation With or Without Atezolizumab
Intervention type:
Drug
Intervention name:
RO7567132 and Atezolizumab
Description:
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as
specified for the respective cohort.
Arm group label:
Part II: RO7567132 Backfill With Atezolizumab
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,
has proven to be ineffective or intolerable, or is not acceptable to the participant.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ Leuven Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Rigshospitalet; Fase 1 Enhed - Onkologi
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Status:
Recruiting
Start date:
September 16, 2024
Completion date:
June 19, 2029
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06537310
