Huntingtons Disease
Conditions
Brief summary
Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course and recovery profile of CSF mHTT lowering in response to RO7234292 (RG6042) treatment after intrathecal (IT) administration of RO7234292 (RG6042) to patients with manifest Hungtington's disease (HD).
Interventions
RO7234292 (RG6042) will be administered in two IT doses of the same dose level at an interval of 28 days during the treatment period (Day 1 and Day 29). Each dose of RO7234292 (RG6042) will be administered as a single IT bolus injection.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Manifest HD diagnosis * Independence Scale score of \>=70. * Genetically confirmed disease by direct deoxyribonucleic acid testing with a cytosine, adenine, and guanine base sequence found in DNA which is translated into glutamine (CAG) age product (CAP) score \> 400. * Ability to read the words red, blue, and green in the patient's native language. * Ability to walk unassisted without a cane or walker and move about without a wheelchair on a daily basis as reviewed at screening and baseline visit. * Ability to undergo and tolerate MRI scans.
Exclusion criteria
* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening. * Current active psychosis, confusional state, or violent behavior. * Any serious medical condition or clinically significant laboratory, vital signs, or ECG abnormalities at screening that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study. * Clinical diagnosis of chronic migraines or history of low pressure headache after lumbar puncture requiring hospitalization or blood patch. * Treatment with investigational therapy within 4 weeks prior to screening or 5 drug elimination half-lives of investigational therapy, whichever is longer. * Concurrent or planned concurrent participation in any interventional clinical study, including explicit pharmacological and non-pharmacological interventions. Observational studies are acceptable. * Unable or unsafe to perform lumbar puncture on the patient. * Previous lumbar surgery that is likely, in the opinion of the Investigator or surgical team, to make IT catheter insertion or IT injection unduly difficult or hazardous. * Poor peripheral venous access. * Scoliosis or spinal deformity making IT injection not feasible in the outpatient setting. * Preexisting intra-axial or extra-axial lesions as assessed by a centrally read MRI scan during the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration) | NA represents: insufficient number of participants with events. |
| Concentrations of RO7234292 in Plasma | Day 1, 2, 3, 4, 5, 28, 29, 30, 43, 71, 127, and follow-up visit (6 months after last study drug administration) | NA represents:insufficient number of participants with events |
| mHTT (Mutant Huntingtin) Concentration in CSF | Days 1, 2, 3, 29, 43, 71, 127 and follow-up visit (6 months after last study drug administration) | CSF Mutant Huntingtin Protein (fmol/L) values at time point visits are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titer and Antibody Subtype, Determined if ADAs Are Identified | Day 1, Day 28, and follow-up visit (6 months after last study drug administration) | The data cannot be reported and the outcome measure is not applicable as no ADA sample was positive. As no ADA, titer and subtype could not be identified |
| Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Up to 6 months | Severity levels levels: 1 = mild; 2 = moderate; 3 = severe used according to NCI-CTCAE grading system. Percentage of participants with 1-3 levels of severities are reported. |
| Amount of RO7234292 in Urine Ae (Micrograms) | Up to 72 hours | — |
| Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | From Screening Day Up To Follow-up Visit (6 months after the last Dosing Day-Day 127) | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety. Scores 1-10 is used, 1 being less and to 10 being severity increasing. Only one time frame was used per score category: from screening to follow-up visit. |
| Incidence of Anti-Drug Antibodies (ADAs) | Day 1, Day 28, and follow-up visit (6 months after last study drug administration) | Percentage of participants who have negative or positive anti-drug antibody affects are reported. |
Countries
Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Level 1 of RO7234292 (RG6042) Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29. | 4 |
| Dose Level 2 of RO7234292 (RG6042) Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29. | 4 |
| Dose Level 3 of RO7234292 (RG6042) Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29. | 4 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Dose Level 3 of RO7234292 (RG6042) | Total | Dose Level 1 of RO7234292 (RG6042) | Dose Level 2 of RO7234292 (RG6042) |
|---|---|---|---|---|
| Age, Continuous | 53.8 Years STANDARD_DEVIATION 6.9 | 47.3 Years STANDARD_DEVIATION 10.5 | 42.3 Years STANDARD_DEVIATION 12.2 | 45.8 Years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 12 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 10 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 | 1 / 4 | 1 / 4 |
Outcome results
Primary
Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)
NA represents: insufficient number of participants with events.
Time frame: Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration)
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 127 | 0.329 ng/mL | Standard Deviation 0.129 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 1 2 hour | 197000 ng/mL | Standard Deviation 71400 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 71 | 1.08 ng/mL | Standard Deviation 0.459 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 29 | 1.08 ng/mL | Standard Deviation 0.773 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Follow-up | NA ng/mL | — |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 43 | 2.81 ng/mL | Standard Deviation 0.906 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 3 48 hour | 888 ng/mL | Standard Deviation 1510 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 2 24 hour | 6220 ng/mL | Standard Deviation 6270 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Follow-up | NA ng/mL | — |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 1 2 hour | 372000 ng/mL | Standard Deviation 132000 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 2 24 hour | 30200 ng/mL | Standard Deviation 17300 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 3 48 hour | 4540 ng/mL | Standard Deviation 3510 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 4 72 hour | NA ng/mL | — |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 29 | 1.51 ng/mL | Standard Deviation 0.757 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 43 | 3.97 ng/mL | Standard Deviation 1.85 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 71 | 1.78 ng/mL | Standard Deviation 0.0919 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 127 | 0.416 ng/mL | Standard Deviation 0.0361 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 4 72 hour | 1270 ng/mL | Standard Deviation 1070 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 2 24 hour | 41100 ng/mL | Standard Deviation 20000 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 71 | 2.92 ng/mL | Standard Deviation 0.57 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 3 48 hour | 6880 ng/mL | Standard Deviation 4830 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 1 2 hour | 933000 ng/mL | Standard Deviation 349000 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 29 | 2.64 ng/mL | Standard Deviation 0.572 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 127 | NA ng/mL | — |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in CSF (Cerebrospinal Fluid) | Day 43 | 6.79 ng/mL | Standard Deviation 1.15 |
Primary
Concentrations of RO7234292 in Plasma
NA represents:insufficient number of participants with events
Time frame: Day 1, 2, 3, 4, 5, 28, 29, 30, 43, 71, 127, and follow-up visit (6 months after last study drug administration)
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 4 72 hour | 0.480 ng/mL | Standard Deviation 0.192 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 28 | NA ng/mL | — |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 29 | 0.142 ng/mL | Standard Deviation 0.143 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 30 | 46.4 ng/mL | Standard Deviation 27.1 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 1 1 hour | 209 ng/mL | Standard Deviation 173 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 43 | 0.249 ng/mL | Standard Deviation 0.14 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 2 24 hour | 30.5 ng/mL | Standard Deviation 31.1 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 3 48 hour | 2.66 ng/mL | Standard Deviation 4.05 |
| Dose Level 1 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 71 | NA ng/mL | — |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 43 | 0.356 ng/mL | Standard Deviation 0.195 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 1 1 hour | 709 ng/mL | Standard Deviation 765 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 71 | NA ng/mL | — |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 4 72 hour | 1.76 ng/mL | Standard Deviation 1.25 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 28 | 0.119 ng/mL | Standard Deviation 0.0273 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 30 | 103 ng/mL | Standard Deviation 52 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 3 48 hour | 5.87 ng/mL | Standard Deviation 5.36 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 29 | 0.135 ng/mL | Standard Deviation 0.132 |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 127 | NA ng/mL | — |
| Dose Level 2 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 2 24 hour | 709 ng/mL | Standard Deviation 765 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 43 | 0.983 ng/mL | Standard Deviation 0.401 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 30 | 317 ng/mL | Standard Deviation 57.6 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 71 | 0.983 ng/mL | Standard Deviation 0.401 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 1 1 hour | 941 ng/mL | Standard Deviation 625 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 2 24 hour | 104 ng/mL | Standard Deviation 84.6 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 3 48 hour | 12.8 ng/mL | Standard Deviation 5.73 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 4 72 hour | 4.20 ng/mL | Standard Deviation 2.11 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 28 | 0.316 ng/mL | Standard Deviation 0.114 |
| Dose Level 3 of RO7234292 (RG6042) | Concentrations of RO7234292 in Plasma | Day 29 | 0.292 ng/mL | Standard Deviation 0.0887 |
Primary
mHTT (Mutant Huntingtin) Concentration in CSF
CSF Mutant Huntingtin Protein (fmol/L) values at time point visits are reported.
Time frame: Days 1, 2, 3, 29, 43, 71, 127 and follow-up visit (6 months after last study drug administration)
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 43 | 83.75 fmol/L | Standard Deviation 41.84 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 3 48H | 325.18 fmol/L | Standard Deviation 215.71 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 1 4H | 177.78 fmol/L | Standard Deviation 92.81 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 29 Pre-dose | 107.46 fmol/L | Standard Deviation 85.36 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 127 | 127.80 fmol/L | Standard Deviation 112.79 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 71 | 138.25 fmol/L | Standard Deviation 127.63 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 2 24H | 204.39 fmol/L | Standard Deviation 180.26 |
| Dose Level 1 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Follow-Up | 132.13 fmol/L | Standard Deviation 115.59 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 127 | 81.05 fmol/L | Standard Deviation 21.84 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 1 4H | 130.35 fmol/L | Standard Deviation 40.16 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 2 24H | 81.74 fmol/L | Standard Deviation 22.38 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 3 48H | 190.85 fmol/L | Standard Deviation 161.19 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 29 Pre-dose | 91.53 fmol/L | Standard Deviation 20.65 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 43 | 66.07 fmol/L | Standard Deviation 1.08 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 71 | 74.86 fmol/L | Standard Deviation 14.38 |
| Dose Level 2 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Follow-Up | 68.77 fmol/L | Standard Deviation 24.49 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 127 | 41.55 fmol/L | Standard Deviation 10.96 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 43 | 68.92 fmol/L | Standard Deviation 21.89 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 1 4H | 99.02 fmol/L | Standard Deviation 50.65 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Follow-Up | 61.55 fmol/L | Standard Deviation 8.84 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 3 48H | 176.59 fmol/L | Standard Deviation 125.52 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 71 | 49.24 fmol/L | Standard Deviation 12.5 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 29 Pre-dose | 55.62 fmol/L | Standard Deviation 16.7 |
| Dose Level 3 of RO7234292 (RG6042) | mHTT (Mutant Huntingtin) Concentration in CSF | Day 2 24H | 127.39 fmol/L | Standard Deviation 42.4 |
Secondary
Amount of RO7234292 in Urine Ae (Micrograms)
Time frame: Up to 72 hours
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Amount of RO7234292 in Urine Ae (Micrograms) | 236.0 micrograms | Geometric Coefficient of Variation 78 |
| Dose Level 2 of RO7234292 (RG6042) | Amount of RO7234292 in Urine Ae (Micrograms) | 207.0 micrograms | Geometric Coefficient of Variation 131 |
| Dose Level 3 of RO7234292 (RG6042) | Amount of RO7234292 in Urine Ae (Micrograms) | 1650.0 micrograms | Geometric Coefficient of Variation 53 |
Secondary
Incidence of Anti-Drug Antibodies (ADAs)
Percentage of participants who have negative or positive anti-drug antibody affects are reported.
Time frame: Day 1, Day 28, and follow-up visit (6 months after last study drug administration)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Day 28 Total Negative | 100 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Baseline Day 1 Total Negative | 100 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Follow-up Total Negative | 100 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Day 28 Total Negative | 100 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Baseline Day 1 Total Negative | 100 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Follow-up Total Negative | 100 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Baseline Day 1 Total Negative | 100 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Follow-up Total Negative | 100 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Incidence of Anti-Drug Antibodies (ADAs) | Day 28 Total Negative | 100 Percentage |
Secondary
Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System
Severity levels levels: 1 = mild; 2 = moderate; 3 = severe used according to NCI-CTCAE grading system. Percentage of participants with 1-3 levels of severities are reported.
Time frame: Up to 6 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 1 | 50 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 3 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 1 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 2 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 2 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 1 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 3 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 2 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 1 | 50 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 2 | 50 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 1 | 75 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 2 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 2 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 3 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 2 | 25 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 1 | 0 Percentage of Participants |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 1 | 25.0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 2 | 75 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 3 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 1 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 2 | 50 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 1 | 50 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 3 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 1 | 25.0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 2 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 1 | 25.0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 2 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 2 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 3 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 2 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 2 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 1 | 25 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 2 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 1 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 2 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Musculoskeletal and connective tissue disorders Level 1 | 50 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 2 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 1 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 2 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Investigations Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Injury, poisoning and procedural complications Level 1 | 50 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Metabolism and nutrition disorders Leve 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 3 | 25.0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Skin and subcutaneous tissue disorders Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 2 | 25.0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 1 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Infections and infestations Level 3 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 3 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 1 | 50 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 2 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Psychiatric disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | General disorders and administration site conditions Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Any Adverse Events Level 1 | 50.0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Gastrointestinal disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 3 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Respiratory, thoracic and mediastinal disorders Level 1 | 25 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Reproductive system and breast disorders Level 1 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Ear and labyrinth disorders Level 2 | 0 Percentage of Participants |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System | Nervous system disorders Level 1 | 75 Percentage of Participants |
Secondary
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety. Scores 1-10 is used, 1 being less and to 10 being severity increasing. Only one time frame was used per score category: from screening to follow-up visit.
Time frame: From Screening Day Up To Follow-up Visit (6 months after the last Dosing Day-Day 127)
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Aborted Attempt | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Interrupted Attempt | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Non-specific Active Suicidal Thoughts | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Non-fatal Suicide Attempt | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | -Active Suicidal Ideation with Any Suicidal Ideation (score 1-5) -Methods (Not Plan) without Intent | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Self-injurious Behavior without Suicidal Intent | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Completed Suicide | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Intent to Act, without Plan Active Suicidal Ideation | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Active Suicidal Ideation with Specific Plan and Intent | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Wish to Be Dead | 0 Percentage |
| Dose Level 1 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Preparatory Acts or Behavior | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Wish to Be Dead | 25 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Aborted Attempt | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Interrupted Attempt | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Intent to Act, without Plan Active Suicidal Ideation | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Completed Suicide | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Non-fatal Suicide Attempt | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Non-specific Active Suicidal Thoughts | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Preparatory Acts or Behavior | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Active Suicidal Ideation with Specific Plan and Intent | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Self-injurious Behavior without Suicidal Intent | 0 Percentage |
| Dose Level 2 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | -Active Suicidal Ideation with Any Suicidal Ideation (score 1-5) -Methods (Not Plan) without Intent | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Self-injurious Behavior without Suicidal Intent | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Wish to Be Dead | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | -Active Suicidal Ideation with Any Suicidal Ideation (score 1-5) -Methods (Not Plan) without Intent | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Intent to Act, without Plan Active Suicidal Ideation | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Active Suicidal Ideation with Specific Plan and Intent | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Preparatory Acts or Behavior | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Aborted Attempt | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Interrupted Attempt | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Non-fatal Suicide Attempt | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Behavior (6-10) -Completed Suicide | 0 Percentage |
| Dose Level 3 of RO7234292 (RG6042) | Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Suicidal Ideation (score 1-5) -Non-specific Active Suicidal Thoughts | 0 Percentage |
Secondary
Titer and Antibody Subtype, Determined if ADAs Are Identified
The data cannot be reported and the outcome measure is not applicable as no ADA sample was positive. As no ADA, titer and subtype could not be identified
Time frame: Day 1, Day 28, and follow-up visit (6 months after last study drug administration)
Population: No data evaluable participants