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Advanced CancerPhase 1NCT02642016

A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors

A Phase 1 study testing CDX-0158 (formerly known as KTN-0158) in people with Advanced Cancer, run by Celldex Therapeutics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
CDX-0158 (formerly known as KTN-0158)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesUnited States
Study dates
Dec 2015to 4 Jun 2019
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

  • Written informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Metastatic or unresectable cancer that expresses KIT as documented in the patient's pathology report.
  • For patients with GIST, patients will have progressed on at least one prior tyrosine kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or PDGFRA-D842V GIST, no prior therapy is required for study entry. Other patients with KIT positive cancers will have progressed on at least one prior therapy.
  • Patients must have at least 1 lesion that is measurable using RECIST guidelines.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of study medication. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause).
  • Nonsterilized males who are sexually active with a female partner of childbearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of study medication.
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  • ECOG status of 0 or 1.
  • Adequate organ function as defined below:
  • Hemoglobin ≥ 9 g/dL. This criterion must be met without transfusion.
  • Absolute neutrophil count ≥ 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN) for cases involving liver metastasis and ≤ 2.5 ×ULN for all other cases
  • Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
  • Serum creatinine ≤ 1.5 g/dL

Who cannot join

  • Receipt of anticancer therapy:
  • Within 3 weeks prior to the first dose of CDX-0158 of any biologic treatment or IV chemotherapy.
  • Within 2 weeks prior to the first dose of CDX-0158 of any oral therapy or 5.5 half lives whichever is longer or following palliative radiation therapy.
  • Concurrent use of hormones for non-cancer related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  • Requirement for chronic immunosuppressive medication including systemic corticosteroids above the physiologic dose (30 mg/day hydrocortisone or the equivalent).
  • Known allergy or past administration reaction including infusion related reaction (IRRs), anaphylactic, or anaphylactoid reactions to any component of the CDX-0158 formulation.
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  • History of clinically significant allergic reactions or atopic disease that may pose an increased risk of severe CDX-0158 IRRs.
  • Symptomatic or untreated central nervous system metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids; if treated, patient must be asymptomatic for 3 months prior to study entry.
  • Other invasive malignancy within 2 years prior to enrollment (localized prostate cancer, cervical carcinoma in situ, non-melanoma skin cancer, or ductal carcinoma in situ of the breast that has/have been surgically cured would not be exclusionary).
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v 4.03 < Grade 2 or normalized to baseline, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
  • Major surgical procedure (as defined by the investigator) within 30 days prior to Study Day 1 or incomplete recovery from any prior surgery.
  • Pregnancy or breast feeding
  • Uncontrolled intercurrent illness that would limit compliance with study requirements or compromise the patient such as ongoing or active infection, symptomatic congestive heart failure, hypertension requiring adjustment of medication, idiopathic and symptomatic hypotension, unstable angina pectoris, clinically significant cardiac arrhythmia including uncontrolled atrial fibrillation, active peptic ulcer disease or gastritis with ongoing blood loss, or psychiatric illness/social situations that would limit compliance or compromise the ability of the patient to give written informed consent.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the study medication or interpretation of patient safety or study results.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study.
  • Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan or prolonged QTc interval of Grade 2 or higher or history of prolonged QTc interval from other drugs.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CDX-0158 in Adult Patients With KIT Positive Advanced Solid Tumors.

This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.

Conditions
Advanced Cancer
Being tested
CDX-0158 (formerly known as KTN-0158)
Keywords
KTN0158, Advanced Cancer, Phase 1, Monoclonal Antibody, Safety and Pharmacokinetics

What participants receive

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

  • CDX-0158 (formerly known as KTN-0158)Biological

    Single agent CDX-0158 until unacceptable toxicity or progressive disease

Study groups in NCT02642016
Study groupRoleWhat they receive
CDX-0158ExperimentalNot described
Receives: Biological: CDX-0158 (formerly known as KTN-0158)

What is being measured

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

  1. Dose limiting toxicities for CDX-0158

    Measured: Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.

Timeline

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

  1. First posted30 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion30 Jan 2018
  4. Study completion4 Jun 2019

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02642016
Sponsor's protocol ID
CDX0158-CL-001
Status last verified
Jun 2019
First submitted
16 Dec 2015
Last updated
12 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CDX-0158 (formerly known as KTN-0158) in people with Advanced Cancer, run by Celldex Therapeutics at 4 sites in United States.

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 14 inclusion and 16 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: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose limiting toxicities for CDX-0158 (time frame: Participants will be evaluated for DLTs from the first adminstration of CDX-0158 through 21 days following initial dosing.). 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 NCT02642016.

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 12 Jun 2019.

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