Studio per la valutazione della sicurezza di HKT288 nei pazienti adulti affetti da carcinoma ovarico avanzato e tumore del rene

Drug: HKT288

Main Inclusion Criteria:

- Advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian
tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal
cell carcinoma who have received or are intolerant to all therapy known to confer
clinical benefit for their disease, as determined by the investigator.

- Tumor sample is available for retrospective CDH6 expression testing

- Eastern Cooperative Oncology Group (ECOG) Performance status =2

Main Exclusion Criteria:

- Patient has central nervous system metastatic involvement. Patients with previously
treated CNS metastases are also excluded.

- Patient with any active or chronic corneal disorders

- Patients with monocular vision or have media opacities or any other condition that
precludes monitoring of the retina or fundus.

- Patients with a history of serious allergic reactions

- Patients with QTcF >470 msec at screening ECG or congenital long QT syndrome

- Any prior history of treatment with maytansine (DM1 or DM4)-based ADC

- Patient have received anti-cancer therapies within the following time frames prior to
the first dose of study treatment:

- Conventional cytotoxic chemotherapy: =4 weeks (= 6 weeks for nitrosoureas and
mitomycin-C)

- Biologic therapy (e.g., antibodies): =4 weeks

- Non-cytotoxic small molecule therapeutics: =5 half-lives or =2 weeks (whichever
is longer)

- Other investigational agents: =4 weeks

- Radiation therapy (except for localized radiotherapy for analgesic purpose or for
lytic lesions at risk of fracture): =4 weeks

- Radiation therapy (localized radiotherapy for analgesic purpose or for lytic
lesions at risk of fracture) =2 weeks

- Major surgery: =2 weeks