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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

Must not have

Clinically significant anorexia within 7 days prior to first dose of study drug.

Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study entry requiring systemic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with stomach or GEJ cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not experienced significant loss of appetite in the week before starting the study drug.

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I do not have any ongoing serious infections needing treatment.

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I do not have active brain metastases or leptomeningeal disease.

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I have not had major surgery within the last 28 days.

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My stomach cancer is of a specific type (squamous cell, undifferentiated, or other).

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My cancer has spread to my bones.

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I have not had radiation therapy in the last 14 days.

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My heart's electrical system has a known issue, or my QT interval is longer than normal.

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I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

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I have had hip bone death or significant hip bone issues seen on an MRI.

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I have had a stem cell or organ transplant in the past.

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I have a history of lung disease or uncontrolled systemic diseases.

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I have not had treatments targeting immune checkpoints or anti-DKK1.

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I am HIV positive.

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My diabetes is under control and my blood levels of potassium, sodium, calcium, and albumin are within normal ranges.

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I need frequent drainage for fluid buildup in my chest or abdomen.

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I have severe heart issues, recent heart attack, or irregular heartbeat.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~12500

Fluorouracil

2014

Completed Phase 3

~11700