Epithelial Ovarian CancerPhase 1NCT02947152
HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma
A Phase 1 study testing HKT288 in people with Epithelial Ovarian Cancer and Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 6 sites in 6 countries.
Trial summary
A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Ovarian Cancer, Renal Cell Carcinoma
- What is being tested?
- HKT288
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 1 Dec 2016to 14 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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
- Conditions
- Epithelial Ovarian Cancer, Renal Cell Carcinoma
- Being tested
- HKT288
- Keywords
- HKT288, CDH6, ADC, maytansine, epithelial ovarian cancer, renal cell carcinoma, RCC
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HKT288Drug
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HKT288 |
| Dose expansion part (RCC arm) | Experimental | Includes patients with clear cell or papillary renal cell carcinoma Receives: Drug: HKT288 |
| Dose expansion part (ovarian cancer arm) | Experimental | Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) Receives: Drug: HKT288 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
Measured: evaluation period is 21 days
Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 6 months on treatment
Best overall response
Measured: 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)
Presence of anti-HKT288 antibodies.
Measured: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
CDH6 expression level
Measured: 3 months
Pharmacokinetics (PK) parameter (AUC) for HKT288
Measured: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Cmax) for HKT288
Measured: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Tmax) for HKT288
Measured: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameters (half-life) for HKT288
Measured: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947152
- Sponsor's protocol ID
- CHKT288X2101
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2016
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02947152
- Acronym / sponsor ID
- CHKT288X2101
- Conditions
- Epithelial Ovarian Cancer, Renal Cell Carcinoma
- Keywords
- HKT288, CDH6, ADC, maytansine, epithelial ovarian cancer, renal cell carcinoma, RCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation part | Experimental | Drug: HKT288Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) and clear cell or papillary renal cell carcinoma |
| Dose expansion part (RCC arm) | Experimental | Drug: HKT288Includes patients with clear cell or papillary renal cell carcinoma |
| Dose expansion part (ovarian cancer arm) | Experimental | Drug: HKT288Includes patients with serous epithelial ovarian cancer (inclusive of fallopian tubal and peritoneal cancer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HKT288Cadherin-6-targeting antibody-drug conjugate for intravenous administration | Drug | Dose escalation part, Dose expansion part (RCC arm), Dose expansion part (ovarian cancer arm) |
Primary outcome
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
Time frame: evaluation period is 21 days
Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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
Time frame: 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)
Time frame: Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
12 secondary outcomes
Concentration vs. time profiles of total antibody (tAb)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6 months on treatment
Best overall response
Time frame: 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)
Presence of anti-HKT288 antibodies.
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
CDH6 expression level
Time frame: 3 months
Pharmacokinetics (PK) parameter (AUC) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Cmax) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Tmax) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameters (half-life) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Results for CHKT288X2101 can be found on the Novartis Clinical Trials Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HKT288 in people with Epithelial Ovarian Cancer and Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Belgium, Japan, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period (time frame: evaluation period is 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.