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Solid TumourPhase 1NCT01516645

Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors

A Phase 1 study testing KHK2898 in people with Solid Tumour, run by Kyowa Kirin Co., Ltd. at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumour
What is being tested?
KHK2898
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSingapore
Study dates
Jan 2012to May 2015
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

Who may be able to join

  • The subject has a histopathological-documented, measurable or non-measurable, locally advanced unresectable primary or metastatic solid tumor unresponsive to standard therapy or for which there is no standard therapy available.
  • The subject has PD during or following the last treatment regimen as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)11.
  • The subject has a life expectancy >3 months.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 at study entry.
  • The subject is ≥ 18 years of age.
  • The subject has a pre-study echocardiogram or multigated acquisition scan with left ventricular ejection fraction ≥ 50%.
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  • The subject has recovered to Grade ≤ 1 by the CTCAE v 4.0313, from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for cancer, with the exception of alopecia or peripheral neuropathy (the latter of which must have resolved to Grade ≤ 2).
  • The subject has preserved organ function as defined below. All parameters must be evaluated within 7 days prior to the first dose of KHK2898.
  • 8-a) Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ×Upper limits of normal (ULN), or ≤ 5.0 × ULN in subjects with metastatic liver disease
  • 8-b) Hemoglobin ≥ 9 g/dl (without transfusion in the preceding 7 days)
  • 8-c) Total bilirubin ≤ 1.5 × ULN
  • 8-d) Creatinine ≤ 1.5 × ULN
  • 8-e) ANC ≥ 1.5 × 109/L (unsupported by growth factors in the preceding 21 days)
  • 8-f) Platelets ≥ 100 × 109/L (without transfusion or growth factor in the preceding 7 days)
  • The subject has provided signed informed consent. Written informed consent must be obtained prior to performing any study-related procedures. For subject < 21 years old who is not married, written informed consent must be taken from the subject and his/her parents/ legal guardians.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test at study entry. Subjects not considered WOCBP are those without menses for 24 consecutive months, and those who have undergone hysterectomy and/or bilateral salpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.

Who cannot join

  • The subject has received anti-cancer chemotherapy, hormonal therapy (other than LH-RH agonists/pure antagonists for prostate cancer, which are allowed to be continued if the subject has already been on one for at least 2 months at the time of enrollment), radiotherapy, immunotherapy, or investigational agents within 4 weeks (6 weeks for mitomycin C and nitrosoureas) prior to the first dose of KHK2898.
  • The subject has received monoclonal antibodies within 4 weeks of the first dose of KHK2898.
  • The subject had major surgery within 4 weeks prior to the first dose of KHK2898.
  • The subject has known symptomatic brain metastases (screening/baseline MRI of the brain is only required when there is clinical suspicion of central nervous system (CNS) involvement or past history of treated brain metastasis). Subjects with treated brain metastasis (radiotherapy and/or surgery) will be eligible if:
  • 4-a) They have completed treatment for their brain metastasis > 4 weeks prior to scheduled study treatment start date;
  • 4-b) They are neurologically stable;
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  • 4-c) They are not receiving corticosteroids or corticosteroids in doses no greater than physiological replacement (e.g., dexamethasone < 1.5 mg/day); and
  • 4-d) They have a screening/baseline MRI scan of the brain that specifically verifies no evidence of CNS hemorrhage and no active gadolinium enhancing lesions; and
  • 4-e) Subjects with primary brain/CNS malignancy (e.g., gliomas, lymphomas) are excluded.
  • The subject has leptomeningeal disease.
  • The subject is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or is lactating.
  • The subject has a significant uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, clinically significant cardiac disease [class II, III, or IV of the New York Heart Association classification (NYHA)],14 unstable angina pectoris, myocardial infarction within 6 months or is post angioplasty or stenting within 6 months, uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg, diastolic BP > 90 mm Hg), found on two consecutive measurements separated by a 1-week period, clinically significant cardiac arrhythmia, or uncontrolled diabetes.
  • The subject has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
  • The subject has known active hepatitis B or C or other active (non-malignant) liver disease.
  • The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety, ability to provide consent, or limit his/her compliance with study requirements.
  • The subject has experienced a hypersensitivity reaction to monoclonal antibodies or other therapeutic proteins, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-HT3 antagonists, or corticosteroids.
  • The subject has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer, b) curatively treated cervical carcinoma in-situ, or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years.
  • The subject requires concomitant medication with any of the following prohibited medications: active prohibited anti neoplastic treatment other than the investigational product KHK2898; other anti-cancer therapies such as cytotoxic chemotherapy; anti-cancer hormonal therapy other than LH-RH agonists/pure antagonists for prostate cancer, which are allowed to be continued if the subject has already been on one for at least 2 months at the time of enrollment; immunotherapies including other monoclonal antibodies, interferons, cancer vaccines, etc; targeted small molecule anti-cancer therapies; and radiation therapy (radiation therapy should be completed prior to enrollment on this study).
  • Prior stem cell or bone marrow transplant.
  • Subjects received vaccination within 8 weeks from the first administration of KHK2898.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: Phase 1, Open-Label, Dose Escalation Study of Anti-CD98 Monoclonal Antibody KHK2898 as Monotherapy in Subjects With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or For Whom No Standard Therapy Is Available

This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

Read the detailed description

The study will be conducted in two parts. In Part 1, a standard 3+3 designed dose escalation phase, subjects will receive KHK2898, administered intravenously, once every 2 weeks. A treatment cycle will consists of total of two doses per cycle. Part 2 of the study will enroll subjects with squamous cell type tumor to receive KHK2898 at a dose to be determined following completion of Part 1.

All subjects will receive study therapy until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the subject, or Investigator decision, up to a maximum of six cycles (approximately six months). After six cycles of KHK2898 therapy, the subject may continue to receive the drug after discussion with the Sponsor and determination that the subject is experiencing a best response of at least stable disease (SD) and is not experiencing any unacceptable toxicities or dose limiting toxicities (DLTs).

Conditions
Solid Tumour
Being tested
KHK2898
Keywords
Squamous cell type tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KHK2898Drug

    injection

Study groups in NCT01516645
Study groupRoleWhat they receive
KHK2898ExperimentalNot described
Receives: Drug: KHK2898

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event collection and assessment

    Adverse Event collection and assessment will be done for all 54 potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).

    Measured: at least 28 days or up to 24 weeks

Secondary outcomes (2)

  1. Evaluate preliminary evidence of efficacy

    Response and progression in subjects with solid tumors and measurable disease will be evaluated using RECIST criteria v 1.1. Evaluations will include: objective response (CR + PR) and clinical benefit (CR + PR + SD).

    Measured: eight weeks

  2. Profile of Pharmacokinetics

    maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), clearance (Cl), and apparent volume of distribution in the terminal elimination phase (Vz).

    Measured: Pre-dose, 1, 2, 4, 6-8, 24, 48, 72, 96, 168, 240-288, 336 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516645
Sponsor's protocol ID
KHK2898-001
Status last verified
Mar 2017
First submitted
13 Jan 2012
Last updated
16 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KHK2898 in people with Solid Tumour, run by Kyowa Kirin Co., Ltd. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. 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 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. 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?

Adverse Event collection and assessment (time frame: at least 28 days or up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516645.

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 16 Mar 2017.

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