HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma

A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of HKT288, Administered Intravenously in Adult Patients With Advanced Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma

A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma

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