Cancer-NeoplasmsPhase 1NCT06537310
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
A Phase 1 study testing RO7567132 and Atezolizumab in people with Cancer-Neoplasms, run by Hoffmann-La Roche at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-Neoplasms
- What is being tested?
- RO7567132 and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 16 Sep 2024to 10 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Spain4 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Clinica Universidad de Navarra Madrid
Madrid, 28027
Fundacion Jimenez Diaz
Madrid, 28040
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Canada3 sites
McGill University Health Center
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
BC Cancer ? Vancouver
Vancouver, British Columbia, V5Z 4E6
Australia2 sites
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Austin Health
Heidelberg, Victoria, 3084
About this study
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
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.
- Conditions
- Cancer-Neoplasms
- Being tested
- RO7567132 and Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7567132 and AtezolizumabDrug
RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
RO7567132 and AtezolizumabDrug
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
| Study group | Role | What they receive |
|---|---|---|
| Part I: RO7567132 Dose Escalation With or Without Atezolizumab | Experimental | Not described Receives: Drug: RO7567132 and Atezolizumab |
| Part II: RO7567132 Backfill With Atezolizumab | Experimental | Not described Receives: Drug: RO7567132 and Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Measured: From baseline to 3 weeks on study
Secondary outcomes (12)
Maximum Concentration (Cmax) Derived for RO7567132
Measured: Up to a maximum of 24 months
Time of Maximum Concentration (Tmax)
Measured: Up to a maximum of 24 months
Minimum Concentration (Cmin)
Measured: Up to maximum of 24 Months
Clearance (CL) or Apparent Clearance (CL/F)
Measured: Up to a maximum of 24 months
Volume of Distribution at Steady State (Vss)
Measured: Up to a maximum of 24 months
Area Under the Curve (AUC) for Various Time Intervals
Measured: Up to a maximum of 24 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
Measured: Up to 24 months
Objective Response Rate (ORR)
Measured: Up to a maximum of 24 months
Disease Control Rate (DCR)
Measured: Up to a maximum of 24 months
Duration of Response (DoR)
Measured: Up to a maximum of 24 months
Progression Free Survival (PFS)
Measured: Up to a maximum of 24 months
Overall Survival (OS)
Measured: Up to a maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start16 Sep 2024
- Primary completion12 May 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical trails, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537310
- Sponsor's protocol ID
- BP44956
- Other IDs
- 2024-512839-70-00
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06537310
- Acronym / sponsor ID
- BP44956
- Conditions
- Cancer-Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I: RO7567132 Dose Escalation With or Without Atezolizumab | Experimental | Drug: RO7567132 and Atezolizumab |
| Part II: RO7567132 Backfill With Atezolizumab | Experimental | Drug: RO7567132 and Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7567132 and AtezolizumabRO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort. | Drug | Part I: RO7567132 Dose Escalation With or Without Atezolizumab |
| RO7567132 and AtezolizumabRO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort. | Drug | Part II: RO7567132 Backfill With Atezolizumab |
Primary outcome
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From baseline to 3 weeks on study
12 secondary outcomes
Maximum Concentration (Cmax) Derived for RO7567132
Time frame: Up to a maximum of 24 months
Time of Maximum Concentration (Tmax)
Time frame: Up to a maximum of 24 months
Minimum Concentration (Cmin)
Time frame: Up to maximum of 24 Months
Clearance (CL) or Apparent Clearance (CL/F)
Time frame: Up to a maximum of 24 months
Volume of Distribution at Steady State (Vss)
Time frame: Up to a maximum of 24 months
Area Under the Curve (AUC) for Various Time Intervals
Time frame: Up to a maximum of 24 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to a maximum of 24 months
Disease Control Rate (DCR)
Time frame: Up to a maximum of 24 months
Duration of Response (DoR)
Time frame: Up to a maximum of 24 months
Progression Free Survival (PFS)
Time frame: Up to a maximum of 24 months
Overall Survival (OS)
Time frame: Up to a maximum of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer-Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical trails study director
Hoffmann-La Roche
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7567132 and Atezolizumab in people with Cancer-Neoplasms, run by Hoffmann-La Roche at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Canada, Australia, Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) (time frame: Up to a maximum of 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.