Klinische Studie
An open-label, multicenter, randomized Phase 2 study of the ATR inhibitor M1774 in combination with other DNA damage response inhibitors in participants with BRCA mutant and/or homologous recombination deficiency (HRD)-positive epithelial ovarian cancer that progressed on prior PARP inhibitor therapy (MS201924)(DDRiver)ATR inhib. M1774 in combi. with other DNA damage response inhib. in particip. with BRCA mutant and/or homologous recomb. deficiency (HRD)-pos. epith. Ov-Ca that progressed on prior PARP inhib. therapy
Krankheitsentität(en)
Weibliches Genital (z.B. Eierstock, Eileiter, Gebärmutter, Scheide, Schamlippen)
Wesentliche Einschlusskriterien- Are ≥ 18 years of age at the time of signing the informed consent
- Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent
- Radiologically confirmed/documented disease progression while on PARPi therapy in either first or second line maintenance setting (bevacizumab maintenance is allowed but not mandated)
- Clinically benefited from PARPi maintenance prior to before documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed
- Prior PARPi in first line maintenance: Participants are allowed 1 additional line of platinum-based chemotherapy between progression and study entry; participants must not have progressed within 6 months of this additional line of platinum-based chemotherapy, defined from the day of the last platinum administration
Wesentliche Ausschlusskriterien- Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the last platinum administration in the second line setting
- History of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor’s Medical Monitor, is considered cured with minimal risk of recurrence within 3 years
- History or known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions
- Organ transplantation, including allogeneic stem cell transplant
- Participants diagnosed with hereditary diseases characterized by genetic defects of DNA repair mechanisms, including ataxia telangiectasia, Nijmegen breakage syndrome, Werner syndrome, Bloom Syndrome, Fanconi anemia, xeroderma pigmentosum, Cockayne syndrome, and trichothiodystrophy
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823401fhk-studienzentrum(at)csj.de