Solid TumourPhase 1NCT06488716
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing RO7759065 and Atezolizumab in people with Solid Tumour, run by Genentech, Inc. at 11 sites in 4 countries.
Trial summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumour
- What is being tested?
- RO7759065 and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 16 Dec 2024to 5 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end-organ function
- 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
- Availability of representative tumor specimens required for patients in select cohorts.
Who cannot join
- Women who are pregnant or breastfeeding
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/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 RO7759065 infusion
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- Primary, untreated, or active central nervous system (CNS) metastases
- Active or history of autoimmune disease or immune deficiency
- Prior allogeneic stem cell or organ transplantation
- Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
- Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States4 sites
University of Colorado
Aurora, Colorado, 80045-2517
Tennesse Oncology - NASH - SCRI - PPDS
Chattanooga, Tennessee, 37404-1130
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Canada3 sites
Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine
Montreal, Quebec, H3T 1E2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2MR
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4R2
Spain3 sites
Clinica Universidad de Navarra-Madrid
Madrid, 28027
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia
Valencia, 46010
Australia1 site
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
About this study
Official title: A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
- Conditions
- Solid Tumour
- Being tested
- RO7759065, Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7759065Drug
Specified dose on specified days
AtezolizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: Dose Escalation | Experimental | Not described Receives: Drug: RO7759065 |
| Phase Ia: Expansion | Experimental | Not described Receives: Drug: RO7759065 |
| Phase Ib: Dose Escalation | Experimental | Not described Receives: Drug: RO7759065; Drug: Atezolizumab |
| Phase Ib: Expansion | Experimental | Not described Receives: Drug: RO7759065; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants iwth Dose Limiting Toxicity (DLTs)
Measured: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Measured: Up to approximately 5 years
Secondary outcomes (5)
Maximum Serum Concentration (Cmax) of RO7759065
Measured: Up to approximately 5 years
Objective Response Rate (ORR)
Measured: Up to Approximately 5 Years
Duration of Response (DOR)
Measured: Up to approximately 5 years
Progression Free Survival (PFS)
Measured: Up to approximately 5 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start16 Dec 2024
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumourStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488716
- Sponsor's protocol ID
- GO45296
- Other IDs
- 2024-513391-17-00
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2024
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06488716
- Acronym / sponsor ID
- GO45296
- Conditions
- Solid Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 5 Jul 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.
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: Dose Escalation | Experimental | Drug: RO7759065 |
| Phase Ia: Expansion | Experimental | Drug: RO7759065 |
| Phase Ib: Dose Escalation | Experimental | Drug: RO7759065, Drug: Atezolizumab |
| Phase Ib: Expansion | Experimental | Drug: RO7759065, Drug: Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end-organ function
- 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
Key exclusion criteria (11 listed)
- Women who are pregnant or breastfeeding
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/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
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 |
|---|---|---|
| RO7759065Specified dose on specified days | Drug | Phase Ia: Dose Escalation, Phase Ia: Expansion, Phase Ib: Dose Escalation, Phase Ib: Expansion |
| AtezolizumabSpecified dose on specified days | Drug | Phase Ib: Dose Escalation, Phase Ib: Expansion |
Primary outcome
Number of Participants iwth Dose Limiting Toxicity (DLTs)
Time frame: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
5 secondary outcomes
Maximum Serum Concentration (Cmax) of RO7759065
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to Approximately 5 Years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065
Time frame: Up to approximately 5 years
Results and safety
The study was stopped early (reason given: Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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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 Trials study director
Genentech, Inc.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7759065 and Atezolizumab in people with Solid Tumour, run by Genentech, Inc. at 11 sites in 4 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Dec 2025. 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 United States, Canada, Spain, Australia. 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?
The study was stopped early (reason given: Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.). Results are not available in the source record.
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?
Number of Participants iwth Dose Limiting Toxicity (DLTs) (time frame: Up to approximately 5 years). 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 24 Dec 2025.