Klinische Studie

A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors(FONTANA)Die Studie prüft, ob das neue Krebsmedikament AZD5335 – allein oder kombiniert – für Patient*innen mit fortgeschrittenen Tumoren sicher ist und und das Tumorwachstum bremsen kann.
Krankheitsentität(en) Lunge
Weibliches Genital (z.B. Eierstock, Eileiter, Gebärmutter, Scheide, Schamlippen)
übergreifende Studien
StudientypInterventionsstudiePhase I/IIA
Wesentliche Einschlusskriterien1. Participants must have histologically confirmed diagnosis of a) Platinum-resistant, relapsed, high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer b) Platinum-sensitive, relapsed, high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer 2. Participants must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy. Platinum resistant-recurrent participants will be included: Participants should have received at least one prior line of platinum containing chemotherapy and then progressed ≤ 180 days after the date of the last dose of platinum. a) Participants who have received only 1 line of platinum-based therapy must have received at least 4 cycles of platinum, and then progressed between > 90 days and ≤ 180 days after the date of the last dose of platinum. b) Previous chemotherapy regimens must have contained bevacizumab as per local practice, unless ineligible. c) Participants may have received PARPi’s as per local practice. d) Participants must provide a tumor sample for retrospective FRα determination by an analytically validated IHC conducted at a central laboratory. Archival or fresh tissue samples are acceptable, except for participants who have received FRα targeted therapies such as FRα-ADCs, subsequent to the available archival sample, in which case, a fresh baseline biopsy will be required. 3. a) All participants must be willing to provide mandatory paired biopsies (pre- and on-treatment). b) Participants must have a lesion amenable for biopsy. As mentioned in the core inclusion criteria, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation. 4. Platinum resistant-recurrent participants will be included: Participants must have received at least one prior line of platinum-containing chemotherapy and then progressed, as detailed below. a) Participants who have received only 1 line of platinum-based therapy must have received at least 4 cycles of platinum, and then progressed between > 90 days and ≤ 180 days after the date of the last dose of platinum. b) Participants who have received 2 or more lines of platinum-based therapy must have progressed on or within 180 days after the date of the last dose of platinum.
Wesentliche Ausschlusskriterien1. Participants with clear cell, mucinous, or sarcomatous histology as well as mixed tumors containing clear cell, mucinous, and/or sarcomatous histologies, or low-grade/borderline ovarian tumors. 2. Participants with primary platinum refractory disease defined as disease that has progressed within 3 months to the first-line platinum-containing chemotherapy. 3. Participants who have received ≥ 4 lines of treatment for the disease under study. 4. Participants who have had prior treatment with a TOP1 inhibitor-ADC, such as ENHERTU® (trastuzumab deruxtecan), TRODELVY® (sacituzumab govitecan) or datopotamab deruxtecan. Previous treatment with systemic TOP1s, such as topotecan, is allowed
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IIIStudienzentrale0941 944 -15535 / -18249studienzentrale.med3(at)ukr.de
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