Solid TumorsPhase 1NCT04642365
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
A Phase 1 study testing RO7296682 and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 10 sites in 6 countries.
Trial summary
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RO7296682 and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 4 Jan 2021to 4 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.
- Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Able to provide the most recent archival tumor tissue samples.
- Adequate cardiovascular, haematological, liver and renal function.
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- Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
- Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
- Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.
Who cannot join
- Pregnancy, lactation, or breastfeeding.
- Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
- Participants with another invasive malignancy in the last two years.
- Participants with known active or uncontrolled infection.
- Positive HIV test at screening.
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- Positive for Hepatitis B and C.
- Vaccination with live vaccines within 28 days prior to C1D1.
- Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
- Participants with wound healing complications.
- Dementia or altered mental status that would prohibit informed consent.
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
- Active or history of autoimmune disease or immune deficiency.
- Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
- Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
- Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Canada3 sites
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 6C2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6
Spain3 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia
Valencia, 46010
About this study
Official title: An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- RO7296682, Atezolizumab
- Keywords
- RG6292
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7296682Drug
RO7296682 will be administered as per the schedules specified in the respective arms.
AtezolizumabDrug
Atezolizumab will be administered as per the schedules specified in the respective arms.
| Study group | Role | What they receive |
|---|---|---|
| Part I | Experimental | Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined. Receives: Drug: RO7296682; Drug: Atezolizumab |
| Part II | Experimental | Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab. Receives: Drug: RO7296682; Drug: Atezolizumab |
| Part III (Exploratory) | Experimental | Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I. Receives: Drug: RO7296682; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Measured: From Day 1 up to the end of safety follow-up (up to 28.5 months)
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Measured: From Day 1 up to the end of safety follow-up (up to 9.3 months)
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities related to RO7296682 and atezolizumab that occurs during the DLT assessment window and not attributable to the underlying disease or an intercurrent illness: Any Grade ≥ 3 hematologic toxicity; Any Grade ≥ 3 non-hematologic toxicity; any other RO7296682-related toxicity considered significant enough to qualify as a DLT in the opinion of the Investigator and after discussion with the Sponsor.
Measured: From Cycle 1 Day 1 up Cycle 2 Day 8 (1 Cycle = 21 days)
Part 2: Objective Response Rate (ORR)
ORR was determined as the percentage of participants with an overall response (OR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Measured: Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Secondary outcomes (13)
Part 1: ORR
ORR was determined as the percentage of participants with an OR of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
Measured: From Day 1 up to end of safety follow-up (up to 28.5 months)
Part 1 and 2: Disease Control Rate (DCR)
DCR was determined as the rate of participants with an OR of either CR, PR, or stable disease (SD) rate as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off to the nearest decimal point.
Measured: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Duration of Response (DoR)
DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD/death (within 30 days from last treatment) were censored on the last day of tumor assessment. Participants without post-baseline (PB) or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Measured: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Progression-Free Survival (PFS)
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD (per RECIST v1.1) or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without PD or death (within 30 days from last treatment) were censored at the last day of tumor assessment. Participants without PB or with all PB assessments but known to be alive were censored at the date of study treatment initiation plus one day.
Measured: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up).
Measured: Part 1: From Day 1 up to end of survival follow-up (36 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682
Measured: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682
Measured: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682
Measured: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682
Measured: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Half-life (t~1/2) of RO7296682
Measured: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1: Serum Concentration of Atezolizumab
1 Cycle = 21 days.
Measured: Predose on Day 1 of Cycles 1 to 9, 12, 14, and 17; End of infusion (EOI) on Day 1 of Cycles 1 and 4; end of study/early discontinuation (up to 28.5 months)
Part 1 and 2: Number of Participants With Treatment-induced Changes in T Regulatory C Ells (Treg) Levels in Blood and/or Tumor as Compared to Baseline
Treg depletion was defined as a reduction to 25% of baseline. As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Measured: Baseline up to 28 days post last dose (up to 24.9 months)
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline
As pre-specified in the protocol, the sponsor had the discretion to discontinue any part of the study at any time. On October 3, 2022, the sponsor decided to terminate Part 2 early due to recruitment challenges. As only 3 participants were enrolled in Part 2: Cohort 1, the sponsor decided not to collect and analyze data for the pharmacodynamic endpoints in Part 2.
Measured: Cycle 1 Day 1 (end of infusion [EOI]); Cycle 1 Day 4 (72 hours post dose); Cycle 1 Day 8 (168 hours post dose); Cycle 1 Day 15 (336 hours post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start4 Jan 2021
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Why it stopped: The sponsor decided to terminate the study early, due to recruitment challenges for Part II and, based on the totality of data generated with a low likelihood of achieving the targeted efficacy, to open Part III.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642365
- Sponsor's protocol ID
- BP42595
- Other IDs
- 2020-003164-82
- Status last verified
- May 2025
- First submitted
- 23 Nov 2020
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04642365
- Acronym / sponsor ID
- BP42595
- Conditions
- Solid Tumors
- Keywords
- RG6292
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study early, due to recruitment challenges for Part II and, based on the totality of data generated with a low likelihood of achieving the targeted efficacy, to open Part III.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I | Experimental | Drug: RO7296682, Drug: AtezolizumabDose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined. |
| Part II | Experimental | Drug: RO7296682, Drug: AtezolizumabDose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab. |
| Part III (Exploratory) | Experimental | Drug: RO7296682, Drug: AtezolizumabDose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.
- Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Able to provide the most recent archival tumor tissue samples.
Key exclusion criteria (16 listed)
- Pregnancy, lactation, or breastfeeding.
- Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
- Participants with another invasive malignancy in the last two years.
- Participants with known active or 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 |
|---|---|---|
| RO7296682RO7296682 will be administered as per the schedules specified in the respective arms. | Drug | Part I, Part II, Part III (Exploratory) |
| AtezolizumabAtezolizumab will be administered as per the schedules specified in the respective arms. | Drug | Part I, Part II, Part III (Exploratory) |
Primary outcome
Part 1: Number of Participants With Adverse Events (AEs)
Time frame: From Day 1 up to the end of safety follow-up (up to 28.5 months)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Part 2: Number of Participants With AEs
Time frame: From Day 1 up to the end of safety follow-up (up to 9.3 months)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 up Cycle 2 Day 8 (1 Cycle = 21 days)
A DLT was defined as the occurrence of any of the following toxicities related to RO7296682 and atezolizumab that occurs during the DLT assessment window and not attributable to the underlying disease or an intercurrent illness: Any Grade ≥ 3 hematologic toxicity; Any Grade ≥ 3 non-hematologic toxicity; any other RO7296682-related toxicity considered significant enough to qualify as a DLT in the opinion of the Investigator and after discussion with the Sponsor.
Part 2: Objective Response Rate (ORR)
Time frame: Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
ORR was determined as the percentage of participants with an overall response (OR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off to the nearest decimal point.
13 secondary outcomes
Part 1: ORR
Time frame: From Day 1 up to end of safety follow-up (up to 28.5 months)
Part 1 and 2: Disease Control Rate (DCR)
Time frame: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Duration of Response (DoR)
Time frame: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Progression-Free Survival (PFS)
Time frame: Part 1: From Day 1 up to end of safety follow-up (up to 28.5 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Overall Survival (OS)
Time frame: Part 1: From Day 1 up to end of survival follow-up (36 months); Part 2: From Day 1 up to end of safety follow-up (up to 9.3 months)
Part 1 and 2: Area Under the Curve From Time of Dosing to the Last Timepoint at the End of the Dosing Period (AUClast) of RO7296682
Time frame: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Maximum Concentration (Cmax) of RO7296682
Time frame: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Time of Maximum Concentration (Tmax) of RO7296682
Time frame: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Volume of Distribution at Steady State Conditions (Vss) of RO7296682
Time frame: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1 and 2: Half-life (t~1/2) of RO7296682
Time frame: Cycles 1 and 4: Predose, end of infusion, and at 24, 72, 168, and 336 hours post-dose (1 Cycle = 21 days)
Part 1: Serum Concentration of Atezolizumab
Time frame: Predose on Day 1 of Cycles 1 to 9, 12, 14, and 17; End of infusion (EOI) on Day 1 of Cycles 1 and 4; end of study/early discontinuation (up to 28.5 months)
Part 1 and 2: Number of Participants With Treatment-induced Changes in T Regulatory C Ells (Treg) Levels in Blood and/or Tumor as Compared to Baseline
Time frame: Baseline up to 28 days post last dose (up to 24.9 months)
Part 1 and 2: Treatment-induced Changes in Teff (T-effector Cell)/Treg Ratio in Blood and/or Tumor as Compared to Baseline
Time frame: Cycle 1 Day 1 (end of infusion [EOI]); Cycle 1 Day 4 (72 hours post dose); Cycle 1 Day 8 (168 hours post dose); Cycle 1 Day 15 (336 hours post dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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
Hoffmann-La Roche
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7296682 and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 10 sites in 6 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 9 inclusion and 16 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Spain, United States, Australia, Belgium and 1 more country. 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?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part 1: Number of Participants With Adverse Events (AEs) (time frame: From Day 1 up to the end of safety follow-up (up to 28.5 months)). The study lists 4 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 21 May 2025.