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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04642365




Registration number
NCT04642365
Ethics application status
Date submitted
23/11/2020
Date registered
24/11/2020

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
Scientific title
An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Secondary ID [1] 0 0
2020-003164-82
Secondary ID [2] 0 0
BP42595
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7296682
Treatment: Drugs - Atezolizumab

Experimental: Part I - Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.

Experimental: Part II - Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.

Experimental: Part III (Exploratory) - Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.


Treatment: Drugs: RO7296682
RO7296682 will be administered as per the schedules specified in the respective arms.

Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 31 months
Primary outcome [2] 0 0
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Up to 31 months
Primary outcome [3] 0 0
Objective Response Rate (ORR) (Part II and III only)
Timepoint [3] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) (Part I only)
Timepoint [1] 0 0
Up to 31 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
Up to 31 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Up to 31 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 31 months
Secondary outcome [6] 0 0
Area under the Curve (AUC) of RO7296682
Timepoint [6] 0 0
Up to 31 months
Secondary outcome [7] 0 0
Minimum Concentration (Cmin) of RO7296682
Timepoint [7] 0 0
Up to 31 months
Secondary outcome [8] 0 0
Maximum Concentration (Cmax) of RO7296682
Timepoint [8] 0 0
Up to 31 months
Secondary outcome [9] 0 0
Time of maximum concentration (Tmax) of RO7296682
Timepoint [9] 0 0
Up to 31 months
Secondary outcome [10] 0 0
Volume of distribution at steady-state conditions (Vss) of RO7296682
Timepoint [10] 0 0
Up to 31 months
Secondary outcome [11] 0 0
Half-life (t~1/2) of RO7296682
Timepoint [11] 0 0
Up to 31 months
Secondary outcome [12] 0 0
Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline
Timepoint [12] 0 0
Up to 31 months
Secondary outcome [13] 0 0
Treatment-induced changes in Teff/Treg (T-effector cell; T-regulatory cell) ratio in blood and/or tumor as compared to baseline
Timepoint [13] 0 0
Up to 31 months

Eligibility
Key inclusion criteria
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.

Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.

* Measurable disease according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Able to provide the most recent archival tumor tissue samples.
* Adequate cardiovascular, haematological, liver and renal function.
* Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
* Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
* Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy, lactation, or breastfeeding.
* Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
* History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
* Participants with another invasive malignancy in the last two years.
* Participants with known active or uncontrolled infection.
* Positive HIV test at screening.
* Positive for Hepatitis B and C.
* Vaccination with live vaccines within 28 days prior to C1D1.
* Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
* Participants with wound healing complications.
* Dementia or altered mental status that would prohibit informed consent.
* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
* Active or history of autoimmune disease or immune deficiency.
* Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
* Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
* Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2024
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter Maccallum Cancer Institute; Clinical Trial Unit - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Denmark
State/province [5] 0 0
København Ø
Country [6] 0 0
Spain
State/province [6] 0 0
Navarra
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04642365