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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Epithelial Ovarian Cancer; Renal Cell Carcinoma

Treatments: Drug: HKT288

Study type: Interventional

Funder types: Industry

Identifiers

NCT02947152

CHKT288X2101

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Dose escalation part

Experimental group

Description:

Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) and clear cell or papillary renal cell carcinoma

Treatment:

Drug: HKT288

Dose expansion part (RCC arm)

Experimental group

Description:

Includes patients with clear cell or papillary renal cell carcinoma

Treatment:

Drug: HKT288

Dose expansion part (ovarian cancer arm)

Experimental group

Description:

Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer)

Treatment:

Drug: HKT288