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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06004245




Registration number
NCT06004245
Ethics application status
Date submitted
16/08/2023
Date registered
22/08/2023

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Scientific title
A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)
Secondary ID [1] 0 0
2023-503170-20-01
Secondary ID [2] 0 0
BP44474
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7589831
Treatment: Drugs - Pembrolizumab

Experimental: RO7589831 Dose Escalation -

Experimental: RO7589831 Monotherapy Expansion -

Experimental: RO7589831 + Pembrolizumab Expansion -


Treatment: Drugs: RO7589831
RO7589831 will be administered orally and once daily (QD) in 3-week cycles.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Timepoint [1] 0 0
From first dose of study drug until 30 days after last dose of study drug (up to approximately 15 months)
Primary outcome [2] 0 0
Incidence of Dose-Limiting Toxicities
Timepoint [2] 0 0
Cycle 1 (1 cycle is 3 weeks)
Secondary outcome [1] 0 0
Maximum Plasma Concentration Observed (Cmax) of RO7589831
Timepoint [1] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [2] 0 0
Time of Maximum Plasma Concentration Observed (Tmax) of RO7589831
Timepoint [2] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [3] 0 0
Area Under the Plasma Concentration-Time Curve (AUC) of RO7589831
Timepoint [3] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [4] 0 0
Apparent Oral Clearance (CL/F) of RO7589831
Timepoint [4] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [5] 0 0
Volume of Distribution (V/F) of RO7589831
Timepoint [5] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [6] 0 0
Terminal Half-Life (T1/2) of RO7589831
Timepoint [6] 0 0
At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)
Secondary outcome [7] 0 0
Objective Response Rate
Timepoint [7] 0 0
From start of study treatment until end of follow-up (up to approximately 36 months)
Secondary outcome [8] 0 0
Disease Control Rate
Timepoint [8] 0 0
From start of study treatment until end of follow-up (up to approximately 36 months)
Secondary outcome [9] 0 0
Duration of Response
Timepoint [9] 0 0
From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [10] 0 0
Progression-Free Survival, as Assessed by the Investigator
Timepoint [10] 0 0
From start of study treatment to the first occurrence of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [11] 0 0
Overall Survival
Timepoint [11] 0 0
From start of study treatment to the time of death from any cause (up to approximately 36 months)

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; for the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic colorectal adenocarcinoma (CRC) with no prior systemic treatment for metastatic disease and not amenable to surgery
* Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting
* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Life expectancy of at least (=)12 weeks
* Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken
* Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability or unwillingness to swallow pills
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency
* Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess
* Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations
* Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c <8% and no urinary ketoacidosis)
* Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration
* Alcohol or drug dependence or abuse
* Patients with known Werner (WRN) syndrome
* Prior treatment with any WRN helicase inhibitor
* Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment
* Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment
* Pregnancy, breastfeeding, or intention of becoming pregnant during the study

Additional Exclusion Criteria for the Combination with Pembrolizumab Only:

* Active or history of autoimmune disease or immune deficiency with some exceptions
* History of interstitial lung disease or pneumonitis
* Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
295
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Denmark
State/province [10] 0 0
København Ø
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Villejuif
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seongnam-si
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Spain
State/province [15] 0 0
Navarra
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester

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
Reference Study ID Number: BP44474 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06004245