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DKK1 Inhibitor
DKN-01 + Pembrolizumab for Endometrial Cancer
Phase 2
Recruiting
Led By Pamela Soliman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests if a drug combo can help control advanced or recurrent endometrial cancer.
Who is the study for?
This trial is for women over 18 with advanced or recurrent endometrioid endometrial cancer that can't be cured by surgery or radiation. Participants may have had up to two prior treatments but not with anti-PD-1/L1 mAbs. They must have measurable disease, be in fair health (ECOG 0-2), and not pregnant or breastfeeding. Exclusions include certain other cancers, recent therapies, vaccines, surgeries, active infections, severe hypersensitivities, autoimmune diseases requiring treatment within the past two years, CNS metastases, and significant heart or gastrointestinal conditions.Check my eligibility
What is being tested?
The study tests if DKN-01 (a DKK1 inhibitor) combined with pembrolizumab controls advanced/recurrent endometrial cancer better than current options. It's a Phase 2 trial where participants receive both drugs to see how effective this combination is against their cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation of organs due to pembrolizumab; fatigue; digestive issues; skin reactions; hormonal changes causing thyroid problems; and potential infusion-related reactions from either drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment2 Interventions
Participants will receive pembrolizumab by vein over about 30 minutes on Day 1 of each cycle for up to 24 months.
Group II: DKN-01Experimental Treatment2 Interventions
Participants will receive DKN-01 by vein over about 30 minutes to 2 hours on Day 1 of each cycle, as well ason Day 15 of Cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
DKN-01
2015
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,416 Total Patients Enrolled
21 Trials studying Endometrial Cancer
5,394 Patients Enrolled for Endometrial Cancer
Leap Therapeutics, Inc.Industry Sponsor
15 Previous Clinical Trials
967 Total Patients Enrolled
2 Trials studying Endometrial Cancer
111 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,086 Total Patients Enrolled
19 Trials studying Endometrial Cancer
4,083 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease treated with medication in the last 2 years.I have not received a live vaccine in the last 30 days.I have not been treated with or worsened after anti-PD-1/L1 therapy.I am currently being treated for an infection.I have been treated with anti-DKK1 therapy before.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My physical ability is rated between fully active and capable of all self-care but unable to work.My cancer does not have mismatch repair deficiency or high microsatellite instability.I have recovered from side effects of previous cancer treatments.I have or had lung inflammation that needed steroids.I have severe heart issues, recent heart attack, or irregular heartbeat.I have had hip bone death or significant hip bone issues seen on an MRI.I have serious stomach or intestine problems.I haven't had major surgery or a serious injury in the last 4 weeks.My cancer is advanced endometrial, not fully treatable by surgery or radiation, and mostly endometrioid or has specific mutations.I have had up to 2 treatments for my cancer's return, excluding chemotherapy with radiation or as initial treatment.I haven't taken any cancer treatments or immunologic agents for the last 4 weeks.My heart's electrical activity has a specific irregularity.My uterine cancer does not have a Wnt-activating mutation.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I had radiotherapy less than 2 weeks before starting the study treatment.I am not pregnant, breastfeeding, or able to become pregnant.I have received an organ or tissue transplant from another person.I have another cancer that is getting worse or was treated in the last 3 years.I am a woman aged 18 or older.I have active brain metastases or cancer in my brain's lining.My liver function tests are within the required range.I have been treated with specific immune therapy for cancer.My blood clotting levels are stable, and I haven't needed a blood transfusion in the last 2 weeks.I agree to a tumor biopsy before treatment, or I had one within the last 3 months.My kidney function, measured by creatinine or GFR, is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: DKN-01
- Group 2: Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does DKN-01 pose any potential risks to human subjects?
"The safety of DKN-01 is rated at 2 as no efficacy data has been obtained yet, though there is some assurance in regards to its security."
Answered by AI
Is the current enrollment period open to new participants?
"Clinicaltrials.gov reports that this clinical trial, which first went live on August 31st 2023 and was last updated 2/27/2023, is no longer enrolling participants. Notwithstanding, there are 300 other trials actively trying to enrol individuals at the moment."
Answered by AI
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