Ovarian Cancer Clinical Trial
HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
Summary
A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma
Eligibility Criteria
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
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There are 5 Locations for this study
Houston Texas, 77030, United States
Melbourne Victoria, 3000, Australia
Leuven , 3000, Belgium
Nagoya Aichi, 466 8, Japan
Barcelona Catalunya, 08035, Spain
Locarno , 6600, Switzerland
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