Phase
Condition
N/ATreatment
RO7589831
Pembrolizumab
VVD-133214
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 confirmedlocally advanced, or metastatic colorectal adenocarcinoma (CRC) with no priorsystemic treatment for metastatic disease and not amenable to surgery
Have received and then progressed following, or are intolerant to, standard therapyin the advanced setting
Presence of measurable disease according to Response Evaluation Criteria in SolidTumors (RECIST) version 1.1
Life expectancy of at least (≥)12 weeks
Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissuefor submission to Sponsor/central laboratory for retrospective central testing; forparticipants without archival tissue, a biopsy from either primary or metastatictumor lesion, deemed medically feasible, must be taken
Adequate hematologic, end-organ, and cardiovascular function, as defined in theprotocol
Exclusion
Exclusion Criteria:
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteralabsorption
Known hypersensitivity or intolerance to ingredients from the study drug formulationincluding patients with rare genetic disorders such as galactosaemia,glucose-galactose intolerance or congenital lactase deficiency
Known uncontrolled central nervous system (CNS) metastases (progressing or requiringanticonvulsants or corticosteroids for symptomatic control) and/or carcinomatousmeningitis
Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including butnot limited to tuberculosis and atypical mycobacterial disease), parasitic, or otherinfection (excluding fungal infections of nail beds), or any major episode ofinfection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of thecourse of antibiotics, except if for tumor fever) or 6 months for any intracranialabscess
Has a positive test at screening for hepatitis B virus, hepatitis C virus, or forhuman immodeficiency virus (HIV), per local diagnostic standard and in accordancewith local laws and regulations
Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined asa screening hemoglobin A1c <8% and no urinary ketoacidosis)
Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 ofstudy 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 initiationof study treatment
Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 daysprior 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
Treatment with organ transplant/graft tissue
Study Design
Connect with a study center
Alfred Hospital
Melbourne, Victoria 3181
AustraliaSite Not Available
Alfred Hospital
Melbourne 2158177, Victoria 2145234 3181
AustraliaSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven 2792482, 3000
BelgiumSite Not Available
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
BCCA-Vancouver Cancer Centre
Vancouver 6173331, British Columbia 5909050 V5Z 4E6
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Rigshospitalet; Onkologisk Klinik
København Ø, 2100
DenmarkActive - Recruiting
Rigshospitalet
København Ø 11746747, 2100
DenmarkSite Not Available
CLCC Leon Berard Lyon
Lyon, 69008
FranceSite Not Available
CLCC Leon Berard Lyon
Lyon 2996944, 69008
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si 1897000, 463-707
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona 3128760, BARCELONA 08035
SpainSite Not Available
Clinica Universidad de Navarra Madrid
Madrid 3117735, Madrid 3117732 28027
SpainSite Not Available
START Madrid. Centro Integral Oncologico Clara Campal
Madrid 3117735, Madrid 3117732 28050
SpainSite Not Available
Clinica Universitaria de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universitaria de Navarra
Pamplona 3114472, Navarre 3115609 31008
SpainCompleted
Hospital Clinico Universitario de Valencia
Valencia 2509954, Valencia 2593113 46010
SpainSite Not Available
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
SpainSite Not Available
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona 3128760, 08035
SpainSite Not Available
Clinica Universidad de Navarra Madrid
Madrid, 28027
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
SpainActive - Recruiting
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, 28050
SpainSite Not Available
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainActive - Recruiting
Royal Marsden Hospital - Fulham
London, SW3 6JJ
United KingdomActive - Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
United KingdomSite Not Available
Sarah Cannon Research Institute
London 2643743, W1G 6AD
United KingdomSite Not Available
The Christie
Manchester, M20 4BX
United KingdomSite Not Available
The Christie
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United KingdomSite Not Available
Royal Marsden Hospital (Sutton)
Sutton 2636503, SM2 5PT
United KingdomCompleted
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Cancer Center
Duarte, California 91010
United StatesSite Not Available
City of Hope at Irvine Lennar
Irvine, California 92618
United StatesSite Not Available
City of Hope Cancer Center
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
City of Hope - Santa Clarita
Valencia 5405288, California 5332921 91355-9512
United StatesActive - Recruiting
Norton Cancer Institute - MDC
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute - MDC
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Duke University
Durham, North Carolina 27705
United StatesSite Not Available
Duke University; Office of Research Contracts
Durham, North Carolina 27705
United StatesActive - Recruiting
Duke University
Durham 4464368, North Carolina 4482348 27705
United StatesCompleted
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma 73170
United StatesSite Not Available
Stephenson Cancer Center Investigational Pharmacy
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oklahoma University Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73170
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
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