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Esophageal NeoplasmsPhase 1P102NCT02013154

A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab

A Phase 1 study testing DKN-01 150 mg, Paclitaxel and Pembrolizumab in people with Esophageal Neoplasms and Adenocarcinoma of the Gastroesophageal Junction, run by Leap Therapeutics, Inc. at 10 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

A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DKN-01 150 mg, Paclitaxel and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
10 sitesUnited States
Study dates
5 May 2014to 11 Jan 2021
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

  • In advanced esophagogastric malignancies:
  • Participants with histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma or gastric adenocarcinoma with Wnt Signaling Alterations
  • Participants must be refractory or intolerant to at least one prior therapy(ies) for metastatic or locally advanced disease
  • If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy
  • Prior treatment with paclitaxel as part of a definitive therapy regimen is acceptable. Patients who are unable to receive paclitaxel for any reason will be allowed to receive DKN-01 as a single agent.
  • Prior treatment anti- programmed death-1 (PD-1)/ anti-PD-ligand 1 (PD-L1) monoclonal antibody (mAb) is permitted in patients provided the patient's disease is primary refractory, and the patient is not intolerant of pembrolizumab. Patients who are not eligible to receive pembrolizumab will be allowed to receive single agent DKN-01
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  • Tumor tissue for mandatory evaluation
  • Must have one or more tumors measurable on radiographic imaging as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with evaluable but not measurable disease per RECIST criteria may be enrolled with the approval of the medical monitor.
  • Must be ≥18 years of age
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. A performance status of 2 on the ECOG scale may be entered upon the review and approval of the medical monitor
  • Disease-free of active second/secondary or prior malignancies for equal to or over 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast
  • Acceptable liver, renal, hematologic and coagulation function
  • For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months following the last dose of study drug

Who cannot join

  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia
  • Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 (male), or history of congenital long QT syndrome.
  • Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy
  • Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) unless HCV RNA is undetected/negative.
  • Serious nonmalignant disease
  • Pregnant or nursing women
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  • History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
  • Systemic central nervous system (CNS) malignancy or metastasis.
  • Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
  • Known osteoblastic bony metastasis
  • History of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
  • Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C)
  • Treatment with low dose chemotherapy concurrent with radiation within 14 days prior to study entry
  • Treatment with radiation therapy within 14 days prior to study entry
  • Treatment with any other investigational agent within 30 days prior to study entry
  • Previously treated with an anti-DKK-1 therapy
  • Participants who have a history of hypersensitivity reactions to TAXOL® or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil). Patients who exhibit these hypersensitivities will be eligible to receive single agent DKN-01.
  • Significant allergy to a pharmaceutical therapy that, in the opinion of the investigator, poses an increased risk to the participant
  • Treatment with corticosteroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to study entry
  • Active substance abuse
  • Receipt of any live vaccines within 30 days before the first dose of study treatment and while participating in the study
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • History of interstitial lung disease
  • Intolerance or severe hypersensitivity (≥Grade 3) to pembrolizumab and/or of its excipients

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Mary Crowley Cancer Center

    Dallas, Texas, 75251

  • Duke University

    Durham, North Carolina, 27710

  • Cedars Sinai Medical Care Foundation

    Los Angeles, California, 90025

  • Tennessee Oncology / Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University / VICC

    Nashville, Tennessee, 37232

  • Smilow Cancer Hospital at Yale - New Haven

    New Haven, Connecticut, 06520

  • CTRC @ The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Multi-part, Phase 1, Multi-center, Open-label Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel or Pembrolizumab in Patients With Relapsed or Refractory Esophagogastric Malignancies

A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies

Read the detailed description

This is a dose-escalating, open-label study conducted in multiple parts (Part A dose-escalation, Parts B-F expansion cohorts, and a monotherapy substudy). Parts A-E (DKN-01 plus paclitaxel) and the DKN-01 monotherapy substudy includes 28-day cycle treatment cycles; Part F (DKN-01 plus pembrolizumab) includes 21-day treatment cycles. Depending on their cancer type, subjects with histologically confirmed recurrent or refractory esophageal, gastro-esophageal junction tumors, or gastric adenocarcinoma will be enrolled in each study part to receive DKN-01 150 mg or 300 mg in combination with paclitaxel or pembrolizumab. Subjects who are unable to receive paclitaxel or pembrolizumab for any reason are allowed to receive single agent DKN-01 300 mg as part of a monotherapy substudy. Results are reported by treatment group, irrespective of the study part in which the subject was enrolled.

Being tested
DKN-01 150 mg, Paclitaxel, Pembrolizumab, DKN-01 300 mg
Medical subject headings
Esophageal Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • DKN-01 150 mgDrug

    Administered by IV infusion

  • PaclitaxelDrug

    Also called Taxol

    Administered by IV infusion

  • PembrolizumabDrug

    Also called Keytruda

    Administered by IV infusion

  • DKN-01 300 mgDrug

    Administered by IV infusion

Study groups in NCT02013154
Study groupRoleWhat they receive
DKN-01 150 mg plus paclitaxelExperimentalDKN-01 150 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22
Receives: Drug: DKN-01 150 mg; Drug: Paclitaxel
DKN-01 300 mg plus paclitaxelExperimentalDKN-01 300 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22
Receives: Drug: Paclitaxel; Drug: DKN-01 300 mg
DKN-01 150 mg plus pembrolizumabExperimentalDKN-01 150 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1
Receives: Drug: DKN-01 150 mg; Drug: Pembrolizumab
DKN-01 300 mg plus pembrolizumabExperimentalDKN-01 300 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1
Receives: Drug: Pembrolizumab; Drug: DKN-01 300 mg
DKN-01 300 mg monotherapyExperimentalDKN-01 300 mg administered on Days 1 and 15
Receives: Drug: DKN-01 300 mg

What is being measured

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

  1. Number of subjects with dose limiting toxicities in each treatment arm

    Measured: Baseline to End of Cycle 1 (each cycle is 28 days, except each cycle is 21 days when DKN-01 is administered with pembrolizumab)

  2. Number of subjects with treatment emergent adverse events related to study treatment (DKN-01 as monotherapy or in combination with paclitaxel or pembrolizumab)

    Measured: Baseline until 30 days after last dose of study drug

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Measured: Baseline to study completion (approximately 3 months)

  2. Duration of Response (DoR)

    Measured: Baseline to study completion (approximately 3 months)

  3. Overall Survival (OS)

    Measured: Baseline to study completion (approximately 3 months)

  4. Progression Free Survival (PFS)

    Measured: Baseline to study completion (approximately 3 months)

Timeline

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

  1. First posted17 Dec 2013 (estimated)
  2. Study start5 May 2014
  3. Primary completion19 Jul 2019
  4. Study completion11 Jan 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013154
Sponsor's protocol ID
DEK-DKK1-P102
Other IDs
DKN-01, LY2812176, KEYNOTE-731
Acronym
P102
Status last verified
Jul 2025
First submitted
11 Dec 2013
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DKN-01 150 mg, Paclitaxel and Pembrolizumab in people with Esophageal Neoplasms and Adenocarcinoma of the Gastroesophageal Junction, run by Leap Therapeutics, Inc. at 10 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 13 inclusion and 26 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Number of subjects with dose limiting toxicities in each treatment arm (time frame: Baseline to End of Cycle 1 (each cycle is 28 days, except each cycle is 21 days when DKN-01 is administered with pembrolizumab)). The study lists 2 primary outcomes in all. 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 NCT02013154.

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 3 Aug 2025.

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