A Study Evaluating Safety, Pharmacokinetics, Pharmacodyna... | NCT04338685 | Trialant
NCT04338685
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Dec 9, 2024Actual
Enrollment
55Actual
Phase
Phase 1
Conditions
Carcinoma, Hepatocellular
Biliary Tract Cancer
Secondary Liver Cancer
Liver Metastases
Interventions
RO7119929
Tocilizumab
Countries
United States
Denmark
Hong Kong
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT04338685
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WP41377
Secondary IDs
Not provided
Brief Title
A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
Official Title
A First In Human, Open Label, Dose Escalation Phase I Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Clinical Activity Profile Of Single Agent RO7119929 (TLR7 Agonist) Administered Orally To Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 16, 2020Actual
Primary Completion Date
Jan 9, 2023Actual
Completion Date
Jan 9, 2023Actual
First Submitted Date
Apr 6, 2020
First Submission Date that Met QC Criteria
Apr 6, 2020
First Posted Date
Apr 8, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2023
Results First Submitted that Met QC Criteria
Oct 23, 2024
Results First Posted Date
Dec 9, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 23, 2024
Last Update Posted Date
Dec 9, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Hepatocellular
Biliary Tract Cancer
Secondary Liver Cancer
Liver Metastases
Keywords
TLR7 Agonist
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
55Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A1-1 mg RO7119929
Experimental
Participants received 1mg RO7119929 every week in 3-week cycles.
Drug: RO7119929
Part A1-3 mg RO7119929
Experimental
Participants received 4 mg RO7119929 every week in 3-week cycles
Drug: RO7119929
Part A1 - 6 mg RO7119929
Experimental
Participants received 6 mg RO7119929 every week in 3-week cycles
Drug: RO7119929
Part A1 -9 mg RO7119929
Experimental
Participants received 9 mg RO7119929 every week in 3-week cycles
Drug: RO7119929
Part B1-5 mg RO7119929
Experimental
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
Drug: RO7119929
Part A2- 2/5/5 mg RO7119929
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7119929
Drug
RO7119929 will be administered orally as a capsule
Part A1 - 6 mg RO7119929
Part A1 -9 mg RO7119929
Part A1-1 mg RO7119929
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLT)
A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.
Baseline up to approximately 14 months
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Baseline up to approximately 14 months
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of one of the following: unresectable advanced or metastatic HCC (including fibrolamellar HCC) not amenable to a curative treatment approach, unresectable advanced or metastatic intrahepatic or perihilar (Klatskin) BTC not amenable to a curative treatment approach, extrahepatic BTC or gallbladder cancer infiltrating the liver or metastasized into the liver with predominant liver disease, not amenable to a curative treatment approach, metastasized colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), Gastric cancer (GC), renal cell carcinoma (RCC), triple negative breast cancer (TNBC), cutaneous melanoma, or ocular melanoma with predominant liver disease not amenable to a curative treatment approach. Participants with other solid tumors with predominant liver disease not amenable to a curative treatment approach might be enrolled after Sponsor approval
Measurable disease with at least one measurable locally untreated liver lesion, as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic and major organ functions
Participants for which there is no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy
Life expectancy of ≥12 weeks, approximated with Royal Marsden Hospital score 0-1 or Gustave Roussy Immune (GRIm) score 0-1. Participants with a Royal Marsden Hospital or GRIm score of ≥2 and a life expectancy of ≥12 weeks according to the investigator's clinical judgement may be enrolled after Medical Monitor approval has been obtained.
For participants with HCC: Child-Pugh score of A6 or better
Exclusion Criteria:
History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days prior to Screening
Evidence of any extra-hepatic primary tumor or metastasis requiring prompt medical intervention
Receipt of prior therapy with a TLR7/8/9 agonist and/or IFN-alpha
Prior chemotherapy, antibody, or other registered or experimental cancer treatment within 3 weeks of study Cycle 1 Day 1. Specifically, no CPI antibody is allowed to be administered within 6 weeks of study Cycle 1 Day 1
Receipt of investigational agent for any other indication within 3 weeks of dosing
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
Local therapy to liver (e.g. radiofrequency ablation, percutaneuous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, and transarterial embolization) within 3 weeks prior to initiation of study treatment, radioembolization within 3 months prior to initiation of study treatment, or non-recovery from side effects of such procedure
Treatment-related toxicities from prior cancer therapy that have not resolved to \
Yoo C, Fabregat-Franco C, Lin CC, Qvortrup C, Oh DY, Yau T, Kim HD, Castet F, Ponz Sarvise M, Hsu C, Rohrberg KS, Lichtenegger FS, Franjkovic I, Kratochwil NA, Bessa J, Rossmann E, Schwalie PC, Rieder N, Poschinger T, Sie CG, Dettling S, Schlenker R, Jiang T, Dai C, Yun H, Hall E, Yeo Te-Ying A, Hoves S, Cannarile MA, Schiff C, Sangro B. First-in-human phase 1 study of RO7119929, an oral TLR7 agonist prodrug, in patients with advanced primary or metastatic liver cancers. J Immunother Cancer. 2026 Mar 9;14(3):e012783. doi: 10.1136/jitc-2025-012783.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
At Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15, the participant were pre-medicated with 500 mL of crystalloid fluid and 500-1000 mg paracetamol orally (PO) or intravenously (IV) at the time of RO7119929 administration (± 30 minutes), followed by 500-1000 mg paracetamol PO or IV 4-6 hours after first drug administration. If no cytokine release syndrome (CRS) is observed, no further premedication was foreseen beyond Cycle 1.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
FG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 17, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Open label, multi-center, single-arm, multiple-ascending dose escalation
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
Drug: RO7119929
Part A2- 2/5/6 mg RO7119929
Experimental
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
Drug: RO7119929
Part A3-4 mg RO7119929
Experimental
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Drug: RO7119929
Drug: Tocilizumab
Part A1-3 mg RO7119929
Part A2- 2/5/5 mg RO7119929
Part A2- 2/5/6 mg RO7119929
Part A3-4 mg RO7119929
Part B1-5 mg RO7119929
Tocilizumab
Drug
Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome.
Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants > 30 kg: 8 mg/kg, for participants < 30 kg: 12mg/kg IV
Part A3-4 mg RO7119929
Actemra
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Progression-Free Survival (PFS) According to RECIST v1.1
Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.
Baseline up to approximately 14 months
Objective Response Rate (ORR) According to RECIST v1.1
ORR is defined as the number of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more).
Baseline up to approximately 14 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death
Baseline up to approximately 14 months
København Ø
2100
Denmark
Queen Mary Hospital; Dept of Medicine
Hong Kong
Hong Kong
Seoul National University Hospital
Seoul
03080
South Korea
Asan Medical Center
Seoul
05505
South Korea
Clínica Universidad de Navarra
Pamplona
Navarre
31620
Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona
08035
Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid
28027
Spain
National Taiwan Uni Hospital
Taipei
10041
Taiwan
Tri-Service General Hospital
Taipei
11490
Taiwan
FG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
FG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
FG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
FG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
FG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
FG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
FG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
FG0004 subjects
FG0016 subjects
FG0023 subjects
FG00310 subjects
FG0044 subjects
FG00518 subjects
FG0064 subjects
FG0075 subjects
FG0081 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0004 subjects
FG0016 subjects
FG0023 subjects
FG00310 subjects
FG0044 subjects
FG00518 subjects
FG0064 subjects
FG0075 subjects
FG0081 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0034 subjects
FG0044 subjects
FG0058 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Study terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
BG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
BG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
BG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
BG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
BG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
BG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
BG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
BG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0016
BG0023
BG00310
BG0044
BG00518
BG0064
BG0075
BG0081
BG00955
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.0± 5.0
BG00157.5± 5.0
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-Limiting Toxicities (DLT)
A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.
Posted
Number
Participants
Baseline up to approximately 14 months
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
OG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
OG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
OG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Units
Counts
Participants
OG0004
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Posted
Number
Participants
Baseline up to approximately 14 months
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Secondary
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/m
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Secondary
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
ID
Title
Description
OG000
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/5 mg.
OG001
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/6 mg.
Units
Counts
Participants
OG000
Secondary
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)
Posted
Median
Full Range
hour
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Secondary
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Posted
Median
Full Range
hours
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
ID
Title
Description
OG000
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/5 mg.
OG001
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/6 mg.
Units
Counts
Participants
OG000
Secondary
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Secondary
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
ID
Title
Description
OG000
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/5 mg.
OG001
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/6 mg.
Units
Counts
Participants
OG000
Secondary
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
Participants in 9 mg cohort were excluded from the Cycle 2 analysis (2 discontinued the study due to DLTs, the other 2 were re-dosed at 3 mg)
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Secondary
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
ID
Title
Description
OG000
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/5 mg.
OG001
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with a step-up dosing of 2/5/6 mg.
Units
Counts
Participants
OG000
Secondary
Progression-Free Survival (PFS) According to RECIST v1.1
Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 14 months
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
Secondary
Objective Response Rate (ORR) According to RECIST v1.1
ORR is defined as the number of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more).
Participants with missing tumor assessments and were not included in the efficacy analysis population for this outcome measure.
Posted
Number
95% Confidence Interval
Participants
Baseline up to approximately 14 months
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
Secondary
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 14 months
ID
Title
Description
OG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
OG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
OG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
OG003
Part A1 - 6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
OG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
Time Frame
Baseline up to 14 months
Description
Number of events includes all occurrences
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A1-1 mg RO7119929
Participants received 1mg RO7119929 every week in 3-week cycles.
3
4
1
4
3
4
EG001
Part A1-3 mg RO7119929
Participants received 3 mg RO7119929 every week in 3-week cycles.
4
6
2
6
6
6
EG002
Part A1 -4 mg RO7119929
Participants received 4 mg RO7119929 every week in 3-week cycles
2
3
2
3
3
3
EG003
Part A1-6 mg RO7119929
Participants received 6 mg RO7119929 every week in 3-week cycles
4
10
4
10
10
10
EG004
Part A1-9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
4
4
4
4
3
4
EG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
8
18
11
18
18
18
EG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
1
4
1
4
4
4
EG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
0
5
2
5
5
5
EG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
0
1
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected1 at risk
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1.
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected6 at risk
EG0026 events2 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA version 25.1.
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
BG00868.0± NAOnly 1 participant analyzed, SD cannot be calculated.
BG00958.1± 10.5
1
BG0035
BG0040
BG00514
BG0060
BG0071
BG0080
BG00923
Male
BG0003
BG0015
BG0022
BG0035
BG0044
BG0054
BG0064
BG0074
BG0081
BG00932
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Not Hispanic or Latino
BG0004
BG0016
BG0023
BG00310
BG0044
BG00518
BG0064
BG0075
BG0081
BG00955
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0003
BG0014
BG0022
BG0034
BG0043
BG0057
BG0062
BG0073
BG0080
BG00928
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
White
BG0001
BG0012
BG0021
BG0036
BG0041
BG00511
BG0062
BG0072
BG0081
BG00927
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
10
OG0044
OG00518
OG0064
OG0075
OG0081
2
OG0042
OG0050
OG0060
OG0070
OG0080
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
OG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
OG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
OG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
OG0064
OG0075
OG0081
Title
Denominators
Categories
Participants with Adverse Events
Title
Measurements
OG0003
OG0016
OG0023
OG00310
OG0043
OG00518
OG0064
OG0075
OG0081
Participants with Serious Adverse Events
Title
Measurements
OG0001
OG0012
OG0022
OG003
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
Title
Denominators
Categories
Cycle 1, after 1st dose (Prodrug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG0044
ParticipantsOG00518
Title
Measurements
OG0001.29± 146
OG0011.94± 46.8
OG0021.85± 62.1
OG003
Cycle 1, after 1st dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Prodrug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
4
OG0013
Title
Denominators
Categories
Prodrug: Cycle 1 Day 15
Title
Measurements
OG0003.49± 116
OG0011.97± 181
Prodrug: Cycle 2 Day 1
Title
Measurements
OG0002.37± 48.9
OG0013.58± 156
Active Drug: Cycle 1 Day 15
Title
Measurements
OG00041.1± 54.9
OG00139.6± 16.3
Active Drug: Cycle 2 Day 1
Title
Measurements
OG00035.9± 52.3
OG00144.4± 32.7
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
Title
Denominators
Categories
Cycle 1, after 1st dose (Prodrug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG0044
ParticipantsOG00518
Title
Measurements
OG0001.02(0.48 to 4.22)
OG0011.50(0.47 to 4.02)
OG0021.02(0.53 to 1.08)
OG003
Cycle 1, after 1st dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Prodrug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
4
OG0013
Title
Denominators
Categories
Prodrug: Cycle 1 Day 15
Title
Measurements
OG0000.51(0.25 to 0.98)
OG0011.02(0.5 to 2.08)
Prodrug: Cycle 2 Day 1
Title
Measurements
OG0000.78(0.42 to 2.07)
OG0012.35(1.45 to 3.05)
Active Drug: Cycle 1 Day 15
Title
Measurements
OG0001.03(0.85 to 1.50)
OG0011.98(1.30 to 3.22)
Active Drug: Cycle 2 Day 1
Title
Measurements
OG0001.43(1.00 to 2.07)
OG0012.35(1.98 to 3.05)
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
Title
Denominators
Categories
Cycle 1, after 1st dose (Prodrug)
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG0044
ParticipantsOG00518
Title
Measurements
OG0006.27± 46.0
OG0014.94± 52.6
OG0023.52± 41.0
OG003
Cycle 1, after 1st dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Prodrug)
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
4
OG0013
Title
Denominators
Categories
Prodrug: Cycle 1 Day 15
Title
Measurements
OG0005.38± 89.6
OG0014.79± 134
Prodrug: Cycle 2 Day 1
Title
Measurements
OG0005.01± 73.9
OG0018.04± 167
Active Drug: Cycle 1 Day 15
Title
Measurements
OG000213± 31.1
OG001170± 23.5
Active Drug: Cycle 2 Day 1
Title
Measurements
OG000178± 24.1
OG001214± 21.4
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
Title
Denominators
Categories
Cycle 1, after 1st dose (Prodrug)
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG0044
ParticipantsOG00518
Title
Measurements
OG0000.896± 3.77
OG0011.54± 31.1
OG0021.02± 22.7
OG003
Cycle 1, after 1st dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Prodrug)
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
Cycle 2, after 4th dose (Active Drug)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00310
4
OG0013
Title
Denominators
Categories
Prodrug: Cycle 1 Day 15
Title
Measurements
OG0001.49± 42.4
OG0011.56± 57.4
Prodrug: Cycle 2 Day 1
Title
Measurements
OG0001.40± 27.8
OG0011.53± 74.5
Active Drug: Cycle 1 Day 15
Title
Measurements
OG0005.11± 24.6
OG0015.84± 14.5
Active Drug: Cycle 2 Day 1
Title
Measurements
OG0005.62± 20.8
OG0016.11± 28.9
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
OG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
OG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
OG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
OG0064
OG0075
OG0081
Title
Denominators
Categories
Title
Measurements
OG0001.2(1.2 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0011.4(1.2 to 1.4)
OG0022.8(1.2 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0031.4(1.3 to 2.8)
OG0041.2(1.2 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0051.6(1.2 to 2.4)
OG0062.7(2.4 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0072.8(1.2 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0083.9(3.9 to 3.9)
OG004
Part A1 -9 mg RO7119929
Participants received 9 mg RO7119929 every week in 3-week cycles
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
OG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
OG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
OG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Units
Counts
Participants
OG0004
OG0016
OG0023
OG0039
OG0043
OG00518
OG0064
OG0074
OG0081
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000(0 to 62.24)
OG0010(0 to 45.93)
OG0020(0 to 70.76)
OG0031(0.28 to 48.25)
OG0040(0 to 70.76)
OG0050(0 to 18.53)
OG0060(0 to 60.24)
OG0070(0 to 60.24)
OG0080(0 to 97.50)
Partial Response
Title
Measurements
OG0000(0 to 62.24)
OG0010(0 to 45.93)
OG0020(0 to 70.76)
OG003
OG005
Part B1-5 mg RO7119929
Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12
OG006
Part A2- 2/5/5 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.
OG007
Part A2- 2/5/6 mg RO7119929
Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.
OG008
Part A3-4 mg RO7119929
Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles
Units
Counts
Participants
OG0004
OG0016
OG0023
OG00310
OG0044
OG00518
OG0064
OG0075
OG0081
Title
Denominators
Categories
Title
Measurements
OG0003.2(1.6 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0015.1(2.9 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0027.9(5.5 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG003NA(5.5 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0042.9(2.9 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG0058.0(3.9 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG006NA(3.4 to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG007NA(NA to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found
OG008NA(NA to NA)In the chosen method to calculate the 95% confidence interval, the upper bound is not found