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DKN-01 + Tislelizumab for Stomach Cancer (DisTinGuish Trial)
Phase 2
Waitlist Available
Research Sponsored by Leap Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of gastric adenocarcinoma or GEJ adenocarcinoma.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
DisTinGuish Trial Summary
This trial is testing a new cancer treatment combo on people with inoperable stomach or gastroesophageal junction cancer.
Who is the study for?
Adults with inoperable, advanced gastric or gastroesophageal cancer who haven't had previous cancer therapy (or have been treatment-free for 6+ months) can join. They must show elevated DKK1 mRNA from a biopsy and agree to contraception use. Exclusions include HER2-positive diagnosis, recent major surgery or chemo, active infections, certain heart conditions, uncontrolled diseases like diabetes, prior treatments with specific antibodies including anti-PD-1/L1/L2 or anti-DKK1 agents.Check my eligibility
What is being tested?
The trial is testing the effectiveness of DKN-01 in combination with Tislelizumab and possibly chemotherapy as first-line or second-line therapy. Patients will receive varying doses of these drugs to see how well they work together against stomach cancers that express a particular gene marker (DKK1).See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in different organs due to Tislelizumab. Chemotherapy could cause fatigue, nausea, hair loss and increased risk of infection. Specific side effects from DKN-01 are not listed but may be similar to other cancer therapies.
DisTinGuish Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with stomach or GEJ cancer.
DisTinGuish Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A and B: Safety and Tolerability of DKN-01 in G/GEJ patients
Part C: Progression Free Survival (PFS) in G/GEJ DKK1 high and overall patients treated with DKN-01 in combination with tislelizumab and chemotherapy vs tislelizumab and chemotherapy as a first-line therapy
Secondary outcome measures
Part A: Objective Response Rate (ORR) in G/GEJ patients treated with DKN-01 in combination with tislelizumab + CAPOX as a first-line therapy
Part A:Disease control rate (DCR) in G/GEJ patients treated with DKN-01 with tislelizumab + CAPOX as a first-line therapy
Part A:Durable clinical benefit (DCB) in G/GEJ patients treated with DKN-01 with tislelizumab + CAPOX as a first-line therapy
+18 moreOther outcome measures
Area Under the Curved (AUC) will be measured.
Concentration of anti-DKN-01 antibodies in human serum in G/GEJ patients treated with DKN-01 in combination with tislelizumab + CAPOX as a first-line therapy.
Concentration of anti-DKN-01 antibodies in human serum in G/GEJ patients treated with DKN-01 in combination with tislelizumab as a second-line therapy
+6 moreDisTinGuish Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Part C Experimental First Line TreatmentExperimental Treatment8 Interventions
Part C experimental patients will receive DKN-01 in combination with tislelizumab and chemotherapy regimen (CAPOX or mFOLFOX6). Part C is restricted to patients who have not had prior systemic therapy for locally advanced or metastatic disease. Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed without disease recurrence for at least 6 months.
Group II: Part B2 Second Line TreatmentExperimental Treatment3 Interventions
Part B patients will receive IV DKN-01 (600 mg) on Days 1 and 15 and IV tislelizumab (200 mg) on Day 1 of each 21-day cycle.
Patients enrolled in Part B are required to have DKK1-high (H-score ≥ 35) G/GEJ adenocarcinoma (pre-screen biopsy) and must have had only 1 prior systemic therapy for locally advanced/metastatic disease (platinum + fluoropyrimidine-based therapy; ±HER2 therapy if applicable). Patients may have received prior neoadjuvant or adjuvant therapy.
Group III: Part B1 Second Line TreatmentExperimental Treatment3 Interventions
Part B patients will receive IV DKN-01 (300 mg) on Days 1 and 15 and IV tislelizumab (200 mg) on Day 1 of each 21-day cycle.
Patients enrolled in Part B are required to have DKK1-high (H-score ≥ 35) G/GEJ adenocarcinoma (pre-screen biopsy) and must have had only 1 prior systemic therapy for locally advanced/metastatic disease (platinum + fluoropyrimidine-based therapy; ±HER2 therapy if applicable). Patients may have received prior neoadjuvant or adjuvant therapy.
Group IV: Part A First Line TreatmentExperimental Treatment5 Interventions
Part A patients will receive IV DKN-01 (300 mg) on Days 1 and 15, IV tislelizumab (200 mg) on Day 1, IV oxaliplatin (130 mg/m2) on Day 1, and oral capecitabine (1000 mg/m2 twice daily [BID]) on Days 1-15 of each 21-day cycle. Part A is restricted to patients who have not had prior systemic therapy for locally advanced or metastatic disease. Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed without disease recurrence for at least 6 months.
Group V: Part C Control First Line TreatmentActive Control8 Interventions
Part C control patients will receive only tislelizumab in combination with chemotherapy regimen (CAPOX or mFOLFOX6). Part C is restricted to patients who have not had prior systemic therapy for locally advanced or metastatic disease. Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed without disease recurrence for at least 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin Calcium
2011
Completed Phase 3
~12290
Fluorouracil
2014
Completed Phase 3
~11540
Oxaliplatin
2011
Completed Phase 4
~2560
Find a Location
Who is running the clinical trial?
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,582 Total Patients Enrolled
Leap Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
795 Total Patients Enrolled
Cynthia Sirard, MDStudy DirectorChief Medical Officer
2 Previous Clinical Trials
261 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not experienced significant loss of appetite in the week before starting the study drug.I do not have any ongoing serious infections needing treatment.I have a serious illness that is not cancer.I agree to use effective birth control during and for 6 months after the study.My side effects from previous cancer treatments have mostly gone away or are stable, except for things like hair loss or numbness.I haven't had any active cancer other than this one in the last 2 years.I do not have active brain metastases or leptomeningeal disease.I do not have any serious mental or physical health issues that could affect my treatment.I am at least 18 years old, or 19 if I'm from the Republic of Korea.I haven't taken steroids or immune suppressants in the last 14 days.I have not had major surgery within the last 28 days.My stomach cancer is of a specific type (squamous cell, undifferentiated, or other).My cancer has spread to my bones.I have not had major surgery or chemotherapy in the last 21 days.I have not received a live vaccine in the last 28 days.I have not had radiation therapy in the last 14 days.My heart's electrical system has a known issue, or my QT interval is longer than normal.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have had hip bone death or significant hip bone issues seen on an MRI.I have not had any serious gut issues like perforations or abnormal connections in the last 6 months.I have had a stem cell or organ transplant in the past.I have a history of lung disease or uncontrolled systemic diseases.I haven't had cancer treatment before, or it's been 6 months since my last treatment without the cancer coming back.I agree to use birth control during and for 6 months after the study.I have not had treatments targeting immune checkpoints or anti-DKK1.I am HIV positive.My diabetes is under control and my blood levels of potassium, sodium, calcium, and albumin are within normal ranges.My cancer worsened during or soon after my first treatment, and I have high DKK1 levels.My liver, kidneys, blood, and clotting functions are all within normal ranges.I am fully active or restricted in physically strenuous activity but can do light work.I need frequent drainage for fluid buildup in my chest or abdomen.My tumor has been tested for PD-L1 and DKK1 levels at a specific lab.I have been diagnosed with stomach or GEJ cancer.I can provide a recent or stored sample of my tumor for testing.I have severe heart issues, recent heart attack, or irregular heartbeat.I have HER2-positive stomach cancer and can't swallow pills due to GI issues. I've had PD-1 or PD-L1 therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: Part B1 Second Line Treatment
- Group 2: Part B2 Second Line Treatment
- Group 3: Part A First Line Treatment
- Group 4: Part C Control First Line Treatment
- Group 5: Part C Experimental First Line Treatment
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.
How many participants are being included in this clinical trial?
"This medical trial necessitates 72 participants who meet the prerequisites. Individuals can take part at either University of Southern California in Los Angeles or AdventHealth Cancer Institute, which is located in Orlando, Florida."
Answered by AI
What medicinal indications are typically handled by DKN-01 300mg?
"DKN-01 300mg is an appropriate treatment for metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and stage iii colon cancer."
Answered by AI
Has the Food and Drug Administration given its stamp of approval to DKN-01 300mg?
"As DKN-01 300mg is a Phase 2 medication, there exists some evidence of safety but no data confirming efficacy. Therefore, it received an overall score of two on our team's scale."
Answered by AI
Are there any available spots to join this research project?
"Affirmative. Data hosted on clinicaltrials.gov demonstrate that this medical trial, initially posted in July 2020, is currently seeking participants to enrol. Approximately 72 patients need to be recruited from 20 different healthcare facilities."
Answered by AI
Could you elaborate on any prior investigations related to DKN-01 300mg?
"Currently, 205 Phase 3 trials for DKN-01 300mg are underway with 642 live studies in total. While the majority of these happen to be based in Adelaide, South Australia, there are a whopping 22040 locations worldwide running experiments with this medication."
Answered by AI
How extensive is the scope of this trial's implementation?
"This medical trial is currently recruiting participants from 20 different locations; this includes Los Angeles, Orlando and Boston amongst others. To minimize any additional stress associated with travel, it's important to select a clinic that is closest to you if enrolling in the study."
Answered by AI
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