Phase
Condition
Neoplasms
Ovarian Cysts
Treatment
M9466
Abiraterone acetate
Prednisone/Prednisolone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Module 1 Part A and Module 2 Part A1: Locally advanced or metastatic disease that isrefractory to standard therapy or for which no standard therapy is judgedappropriate by the Investigator
Module 1 Part A2: Histologically or pathologically confirmed advanced or metastaticCRPC or EOC
Eastern Cooperative Oncology Group Performance Status less than or equal to (<=) 1
Life expectancy of more than 6 months
Have adequate hematologic function
Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior tostarting study intervention with M9466 (± tuvusertib)
Module 3 Part A1:
Histologically or pathologically confirmed diagnosis of prostate cancer
Metastatic disease documented by positive bone scan or metastatic lesions on CTor MRI
Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) ormetastatic hormone-sensitive prostate cancer (mHSPC) are allowed. For mCRPC,serum testosterone levels ≤ 50 /dL (≤ 1.75 nmol/L).
Ongoing ADT with a GnRH agonist or antagonist for participants who have notundergone bilateral orchiectomy must be initiated before first dose and mustcontinue throughout the study.
Candidate for treatment with ·abiraterone acetate.
Prior anticancer therapy allowed for mHSPC or mCRPC
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
Persistence of Adverse Events related to any prior treatments that have notrecovered to Grade less than 1 by NCI Common Terminology Criteria for AdverseEvents- v5.0 unless AEs are clinically nonsignificant and/or stable on supportivetherapy in the opinion of the Investigator (e.g. neuropathy or alopecia)
Participant has a history of additional malignancy within 5 years before the date ofenrollment other than disease under study (exceptions are squamous and basal cellcarcinomas of the skin and carcinoma in situ of the cervix, benign prostateneoplasm/hypertropia, or malignancy that in the opinion of the Investigator, withconcurrence of the Sponsor's Medical Monitor, is considered cured with minimal riskof recurrence within 3 years)
Participants with known brain metastases, except if clinically controlled, which isdefined as individuals with Central Nervous System (CNS) tumors that have beentreated, are asymptomatic and who have discontinued steroids (for the treatment ofCNS tumors) for more than 28 days
Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting,uncontrolled diarrhea, known malabsorption, significant small bowel resection orgastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacementtherapy), and/or other situations that may preclude adequate absorption of oralmedications
Cerebrovascular accident or stroke
Module 3 only:
Current evidence of any of the following:
- Any medical condition that would make prednisone (or equivalent) usecontraindicated.
- Any chronic medical condition requiring a higher dose of corticosteroidthan 10 mg prednisone (or equivalent) once daily.
History of uncontrolled pituitary or adrenal dysfunction
Hypokalemia
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
Cancer Research SA
Adelaide 2078025,
AustraliaSite Not Available
GenesisCare North Shore (Oncology)
St Leonards,
AustraliaSite Not Available
GenesisCare North Shore (Oncology)
St Leonards 8029783,
AustraliaSite Not Available
Please Contact the Communication Center
Darmstadt, 64293
GermanySite Not Available
Harasanshin Hospital
Fukuoka 1863967,
JapanSite Not Available
Harasanshin Hospital
Fukuoka-shi,
JapanSite Not Available
National Cancer Center Hospital East - Dept of Experimental Therapeutics
Kashiwa-shi,
JapanSite Not Available
Cancer Institute Hospital of JFCR
Koto-ku,
JapanSite Not Available
NHO Kumamoto Medical Center - Dept of Urology
Kumamoto 1858421,
JapanSite Not Available
NHO Kumamoto Medical Center - Dept of Urology
Kumamoto-shi,
JapanSite Not Available
Cancer Institute Hospital of JFCR
Kōtoku 2128852,
JapanSite Not Available
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam 6876792,
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848,
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848,
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848,
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul 1835848,
South KoreaSite Not Available
Hospital HM Nou Delfos - START Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona,
SpainActive - Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona,
SpainSite Not Available
Hospital HM Nou Delfos - START Barcelona
Barcelona 3128760,
SpainSite Not Available
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona 3128760,
SpainSite Not Available
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
Barcelona 3128760,
SpainSite Not Available
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid,
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid,
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid 3117735,
SpainSite Not Available
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid 3117735,
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid 3117735,
SpainSite Not Available
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon,
SpainSite Not Available
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón 3112989,
SpainSite Not Available
Please Contact U.S. Medical Information
Rockland, Massachusetts 02370
United StatesSite Not Available
NEXT Oncology - PARENT
New York, New York 10065
United StatesSite Not Available
NEXT Oncology - PARENT
New York 5128581, New York 5128638 10065
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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