Phase
Condition
Neoplasms
Neoplasm Metastasis
Treatment
Avelumab
M1774
Lartesertib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Parts A1, A1.1, A1.2, A2, A3, and A2/3: Participants with metastatic or locallyadvanced unresectable solid tumors refractory to standard therapy or for which nostandard therapy is judged appropriate by the Investigator, which may conveyclinical benefit, or who cannot tolerate standard of care treatment
Parts A1.1 and A1.2: Triple negative breast cancer, epithelial ovarian cancer,castrate resistant prostate cancer, urothelial cancer, endometrial cancer, andcolorectal cancer independent of mutation status.
Part A2: Participants with advanced prostate cancer whose tumor carries a geneticloss of function (LoF) mutation(s) in the gene ataxia telangiectasia mutated (ATM).No more than 3 prior lines of therapy for castrate resistant disease. Prior therapymust have included a taxane and a novel antiandrogen (example [e.g.] enzalutamide).
Part A3: Participants with advanced endometrial cancer whose tumor carries a geneticLoF mutation(s) in the gene AT-rich interaction domain 1A (ARID1A). Prior therapymust have included a platinum agent. Prior therapy must also have included acheckpoint inhibitor if the participant has mismatch repair (MMR)-deficientendometrial cancer. Note for Parts A2/A3: Participants with ATM LoF mutated prostatecancer and ARID1A LoF mutated endometrial cancer should be prioritized to therespective expansion arms instead of being enrolled in Part A1.1. The presence ofATM and ARID1A LoF mutations will be determined according to historic data collectedprior to prescreening, generated by an assay with appropriate regulatory status, ineither tumor or liquid biopsy. The Sponsor will confirm that mutations certified byhistoric data fulfil this definition.
Participants with eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, with estimated life expectancy of at least 3 months
Adequate hematological, hepatic, and renal function as defined in the protocol
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
Participants with any condition, including any uncontrolled disease state other thanwith metastatic or locally advanced unresectable solid tumors, that in theInvestigator's opinion constitutes an inappropriate risk or a contraindication forparticipation in the study or that could interfere with the study objectives,conduct, or evaluation
Participants with a known additional malignancy that is progressing and/or requiresactive treatment
Participants with carcinomatous meningitis are excluded regardless of clinicalstability
Participants with serious gastrointestinal bleeding within 3 months, refractorynausea and vomiting, uncontrolled diarrhea, known malabsorption, significant smallbowel resection or gastric bypass surgery, use of feeding tubes, other chronicgastrointestinal disease, and/or other situations that may preclude adequateabsorption of oral medications
Participants with organ transplantation, including allogeneic stem cell transplant
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
Royal North Shore Hospital
St Leonards,
AustraliaSite Not Available
Calvary Mater Newcastle - PARENT
Waratah,
AustraliaSite Not Available
Princess Margaret Cancer Centre
Toronto, M5G 2C1
CanadaSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaSite Not Available
Korea University Guro Hospital
Seoul, 08308
South KoreaSite Not Available
Samsung Medical Center
Seoul, 06351
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, 03722
South KoreaSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South KoreaSite Not Available
Korea University Guro Hospital
Seoul 1835848, 08308
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul 1835848, 03722
South KoreaSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul 1835848, 06591
South KoreaSite Not Available
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona,
SpainSite Not Available
Hospital QuironSalud Barcelona - Next Oncology
Barcelona, 08023
SpainSite Not Available
Hospital QuironSalud Barcelona - Next Oncology
Barcelona 3128760, 08023
SpainSite Not Available
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid, 28050
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid,
SpainSite Not Available
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid, 28223
SpainSite Not Available
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid 3117735, 28050
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid 3117735, 28223
SpainSite Not Available
Providence Medical Foundation
Santa Rosa, California 95403
United StatesSite Not Available
University of Miami School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Augusta University - formerly Georgia Regents University
Augusta, Georgia 30912
United StatesSite Not Available
The University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66205
United StatesSite Not Available
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Mary Crowley Cancer Research Centers
Dallas, Texas 75230
United StatesSite Not Available
University of Texas M. D. Anderson Cancer Center - Partner
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available

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