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A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT06004245
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 monotherapy in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. RO7589831 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, RO7589831 may be able to block the growth of these types of cancer.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: RO7589831 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is an open label study. Participants will be assigned to dose cohorts in the order in which they are enrolled. However, if two or more cohorts in the same part of the study are open for enrollment at the same time, participants will be randomized into these cohorts.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)
Actual Study Start Date : January 25, 2024
Estimated Primary Completion Date : December 22, 2025
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part I: RO7589831 Dose Escalation Drug: RO7589831
RO7589831 will be administered orally and once daily (QD) in 3-week cycles.
Experimental: Part II: RO7589831 Dose Expansion Drug: RO7589831
RO7589831 will be administered orally and once daily (QD) in 3-week cycles.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: From first dose of study drug until 30 days after last dose of study drug (up to approximately 15 months) ]
  2. Incidence of Dose-Limiting Toxicities [ Time Frame: Cycle 1 (1 cycle is 3 weeks) ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration Observed (Cmax) of RO7589831 [ Time Frame: 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) ]
  2. Time of Maximum Plasma Concentration Observed (Tmax) of RO7589831 [ Time Frame: 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) ]
  3. Area Under the Plasma Concentration-Time Curve (AUC) of RO7589831 [ Time Frame: 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) ]
  4. Apparent Oral Clearance (CL/F) of RO7589831 [ Time Frame: 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) ]
  5. Volume of Distribution (V/F) of RO7589831 [ Time Frame: 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) ]
  6. Terminal Half-Life (T1/2) of RO7589831 [ Time Frame: 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) ]
  7. Objective Response Rate [ Time Frame: From start of study treatment until end of follow-up (up to approximately 36 months) ]
  8. Disease Control Rate [ Time Frame: From start of study treatment until end of follow-up (up to approximately 36 months) ]
  9. Duration of Response [ Time Frame: 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) ]
  10. Progression-Free Survival, as Assessed by the Investigator [ Time Frame: 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) ]
  11. Overall Survival [ Time Frame: From start of study treatment to the time of death from any cause (up to approximately 36 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Have a locally confirmed microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor
  • Have received and then progressed following or are intolerant to at least 1 standard treatment regimen 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

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)
  • Alcohol or drug dependence or abuse
  • Patients with known Werner (WRN) syndrome
  • Prior treatment with any WRN helicase inhibitor
  • Pregnancy, breastfeeding, or intention of becoming pregnant during the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06004245


Contacts
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Contact: Reference Study ID Number: BP44474 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
City of Hope at Irvine Lennar Recruiting
Irvine, California, United States, 92618
United States, North Carolina
Duke University; Office of Research Contracts Recruiting
Durham, North Carolina, United States, 27705
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Belgium
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Canada, British Columbia
BCCA-Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G 2M9
Denmark
Rigshospitalet; Onkologisk Klinik Recruiting
København Ø, Denmark, 2100
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Vall d?Hebron Institute of Oncology (VHIO), Barcelona Recruiting
Barcelona, Spain, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología Recruiting
Madrid, Spain, 28027
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC Recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Recruiting
Valencia, Spain, 46010
United Kingdom
Royal Marsden Hospital - Fulham Recruiting
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT06004245    
Other Study ID Numbers: BP44474
2023-503170-20-00 ( Registry Identifier: EU Trial Number )
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

Roche's Global Policy on the Sharing of Clinical Information describes studies which are eligible for data sharing and how to request access (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Deficient mismatch repair
dMMR
Microsatellite instability
MSI
Additional relevant MeSH terms:
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Microsatellite Instability
Genomic Instability
Pathologic Processes