NCT02947152

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2016

Geographic Reach
6 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2017

Completed
Last Updated

December 8, 2020

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

September 12, 2016

Last Update Submit

December 6, 2020

Conditions

Epithelial Ovarian CancerRenal Cell Carcinoma

Keywords

HKT288CDH6ADCmaytansineepithelial ovarian cancerrenal cell carcinomaRCC

Outcome Measures

Primary Outcomes (4)

  • Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period

    evaluation period is 21 days

  • Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)

    Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)

  • Tolerability as assessed by numbers of dose changes or interruptions

    Until last dose of study treatment (=average of approximately 6 months after first dose)

  • Safety assessed by severity of adverse events (AEs) and serious adverse events (SAEs)

    Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)

Secondary Outcomes (12)

  • Concentration vs. time profiles of total antibody (tAb)

    On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose). 1 cycle is 21 days, increases to 28 days if there is a dose delay of 7 days for the start of next dose

  • Objective response rate

    every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)

  • Duration of response

    every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)

  • Progression-free survival

    every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)

  • Disease Control Rate

    At 6 months on treatment

  • +7 more secondary outcomes

Study Arms (3)

Dose escalation part

EXPERIMENTAL

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

Drug: HKT288

Dose expansion part (RCC arm)

EXPERIMENTAL

Includes patients with clear cell or papillary renal cell carcinoma

Drug: HKT288

Dose expansion part (ovarian cancer arm)

EXPERIMENTAL

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

Drug: HKT288

Interventions

HKT288DRUG

Cadherin-6-targeting antibody-drug conjugate for intravenous administration

Dose escalation partDose expansion part (RCC arm)Dose expansion part (ovarian cancer arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466 8560, Japan

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Locarno, 6600, Switzerland

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

October 27, 2016

Study Start

December 1, 2016

Primary Completion

September 14, 2017

Study Completion

September 14, 2017

Last Updated

December 8, 2020

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)BE(1)AU(1)ES(1)US(1)JP(1)