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

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT02947152

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 5 Locations for this study

See Locations Near You

Novartis Investigative Site
Houston Texas, 77030, United States
Novartis Investigative Site
Melbourne Victoria, 3000, Australia
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Nagoya Aichi, 466 8, Japan
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Locarno , 6600, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT02947152

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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