HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
NCT ID: NCT02947152
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2016-12-01
2017-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose escalation part
Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) and clear cell or papillary renal cell carcinoma
HKT288
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Dose expansion part (RCC arm)
Includes patients with clear cell or papillary renal cell carcinoma
HKT288
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Dose expansion part (ovarian cancer arm)
Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer)
HKT288
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HKT288
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Tumor sample is available for retrospective CDH6 expression testing
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Locarno, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CHKT288X2101 can be found on the Novartis Clinical Trials Results Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHKT288X2101
Identifier Type: -
Identifier Source: org_study_id