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Cancer Vaccine
ATP128 + VSV-GP128 + BI 754091 for Colorectal Cancer (KISIMA-01 Trial)
Phase 1
Waitlist Available
Led By Scott Kopetz
Research Sponsored by Amal Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 as determined by the local site investigator/radiologist assessment.
Must not have
Has known history of or is positive for hepatitis B (hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV RNA)
Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 470 msec, Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block, Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old, or any concomitant medication known to prolong the QT interval (according to institutional guidelines), Ejection fraction (EF) < 55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g. echocardiogram [ECHO], multi-gated acquisition scan [MUGA]. A historic measurement of EF no older than 6 months prior to first study treatment administration can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or the treating physician or both
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is assessing the safety and tolerability of the ATP128 vaccine when given alone or in combination with BI 754091. The trial will also assess the efficacy of the combination of ATP128 and VSV-GP128 when given in combination with BI 754091 in patients with microsatellite stable colorectal cancer.
Who is the study for?
Adults with stage IV colorectal cancer who have failed standard therapies or are in stable condition after first-line treatment. They must be able to undergo biopsies, not pregnant or breastfeeding, willing to use contraception, and without certain health conditions like autoimmune diseases, active infections, or heart issues.
What is being tested?
The trial is testing ATP128 alone or with BI 754091 (Ezabenlimab), and a prime-boost regimen of ATP128 + VSV-GP128 with BI 754091. It's for patients whose cancers haven't responded well to PD-1 blockade treatments.
What are the potential side effects?
Potential side effects may include typical reactions related to vaccines and immune therapies such as injection site reactions, flu-like symptoms, fatigue, possible organ inflammation due to immune response activation but specific side effect profiles will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I have at least one tumor that can be measured on a scan.
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I am willing to have two liver biopsies.
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I am 18 years old or older.
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My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.
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I have a liver lesion that can be biopsied multiple times.
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I am willing to have two liver biopsies.
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I have had standard treatments for stage IV colon cancer.
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My kidney function, measured by creatinine clearance, is good.
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My cancer did not worsen after receiving initial chemotherapy.
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I am eligible for surgery to remove liver metastases and possibly the primary tumor with the goal of no visible cancer remaining.
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My kidney function, measured by creatinine clearance, is good.
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I completed my first round of treatment for stage IV disease and my condition is stable or improved.
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My stage IV colon cancer has spread to the liver only.
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My stage IV colon cancer has not responded to standard treatments.
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I have stage IV colon cancer and standard treatments haven't worked for me.
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I have had standard chemotherapy for stage IV colon cancer.
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My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had hepatitis B or C.
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My heart health does not meet the specific criteria listed, including issues with my heart's rhythm or a low ejection fraction.
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I am not allergic to any of the drugs or their components used in this study.
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I have not had experimental immunotherapy or drugs targeting PD-1, PD-L1, or CTLA-4.
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I am not on high-dose steroids or immunosuppressants.
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I need skin medication that affects my immune system.
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I have been treated with VSV-based therapy before.
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I have undergone more than one treatment for stage IV disease.
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I have had pneumonitis in the last 5 years.
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I have a blockage in my intestines.
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I have or had lung inflammation that needed steroids, or my oxygen level is below 92% without aid.
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I have been diagnosed with brain swelling.
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I haven't had any radiotherapy in the last 2 weeks, or 4 weeks if it was for my brain, and I've recovered from any side effects.
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I am currently being treated for a long-term or active infection.
Select...
My cancer has spread to my brain or its coverings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate safety and tolerability by measure of incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
valuate anti-tumor effect of study treatment by measure of Progression-free survival (PFS)
Secondary study objectives
Confirm recommended phase 2 dose (RP2D) of study treatment
Evaluate anti-tumor effect of study treatment by measure of Duration of Response (DoR)
Evaluate anti-tumor effect of study treatment by measure of Overall Response (OR)
+3 moreOther study objectives
Assess shedding and viremia of VSV-GP128
Biopsy
Evaluate pharmacodynamic effects of study treatment
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 4bExperimental Treatment3 Interventions
15 patients with stage IV MSS/MMRp CRC with liver-limited disease
Group II: Cohort 4aExperimental Treatment3 Interventions
24 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Group III: Cohort 3Experimental Treatment3 Interventions
6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Group IV: Cohort 2cExperimental Treatment2 Interventions
19 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Group V: Cohort 2bExperimental Treatment2 Interventions
15 patients with stage IV MSS/MMRp CRC with liver-limited disease
Group VI: Cohort 2aExperimental Treatment2 Interventions
5 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Group VII: Cohort 1bExperimental Treatment2 Interventions
6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Group VIII: Cohort 1aExperimental Treatment1 Intervention
6 patients with stage IV CRC who failed SoC therapies
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 754091
2018
Completed Phase 1
~510
Find a Location
Who is running the clinical trial?
Amal TherapeuticsLead Sponsor
1 Previous Clinical Trials
85 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,549 Previous Clinical Trials
15,534,384 Total Patients Enrolled
Scott KopetzPrincipal InvestigatorMD Anderson
1 Previous Clinical Trials
102 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a liver lesion that can be biopsied multiple times.I can take care of myself and am up and about more than half of my waking hours.I have at least one tumor that can be measured on a scan.This is a specific group within the study.I am willing to have two liver biopsies.I have or had hepatitis B or C.My side effects from previous treatments are mild, except for possible hair loss, mild nerve pain, or tiredness.I am 18 years old or older.My heart health does not meet the specific criteria listed, including issues with my heart's rhythm or a low ejection fraction.My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.I am not allergic to any of the drugs or their components used in this study.I have a liver lesion that can be biopsied multiple times.I am willing to have two liver biopsies.I haven't had major surgery in the last 3 months.I haven't had chemotherapy or targeted therapy in the last 15 days.I have had standard treatments for stage IV colon cancer.I have not had experimental immunotherapy or drugs targeting PD-1, PD-L1, or CTLA-4.I am not on high-dose steroids or immunosuppressants.I have a cancer lesion that can be safely biopsied twice.My kidney function, measured by creatinine clearance, is good.I need skin medication that affects my immune system.I have an autoimmune disease, but it's not vitiligo or childhood asthma.I am not pregnant or breastfeeding and either cannot become pregnant or will use effective birth control.I have not received any live vaccines in the last 30 days.My liver enzymes are within the required limits.I have at least one tumor that can be measured on a scan.My cancer did not worsen after receiving initial chemotherapy.You are expected to live for at least one year.I have been treated with VSV-based therapy before.This applies to all groups of people in the study.I have undergone more than one treatment for stage IV disease.Participants are expected to live for at least 3 more months.I have had pneumonitis in the last 5 years.I am eligible for surgery to remove liver metastases and possibly the primary tumor with the goal of no visible cancer remaining.I have a blockage in my intestines.I haven't taken any monoclonal antibody treatments recently, except for Avastin, Erbitux, or Vectibix.My kidney function, measured by creatinine clearance, is good.My bilirubin levels are within the normal range, or I have Gilbert's Syndrome with acceptable bilirubin levels.I have no other cancers needing treatment or that have been active in the last 2 years, except for minor skin cancers or other specific non-aggressive types.My bilirubin levels are within the normal range, or I have Gilbert's Syndrome with acceptable bilirubin levels.I had treatment for stage II or III colorectal cancer, but it's been over 6 months since that treatment ended.I completed my first round of treatment for stage IV disease and my condition is stable or improved.I have or had lung inflammation that needed steroids, or my oxygen level is below 92% without aid.My stage IV colon cancer has spread to the liver only.I can take care of myself and perform daily activities.I have not taken Tamoxifen in the last month.You are expected to live for at least 6 more months.I have been vaccinated against metastatic colorectal cancer.I am 18 years old or older.I have been diagnosed with brain swelling.My stage IV colon cancer has not responded to standard treatments.I have stage IV colon cancer and standard treatments haven't worked for me.You are expected to live for at least 3 more months.I have had standard chemotherapy for stage IV colon cancer.My side effects from previous treatments are mild, except for possible hair loss, mild nerve pain, or tiredness.My kidney, liver, and blood tests are normal as of last week.My colorectal cancer is confirmed and not linked to a specific genetic mismatch repair deficiency.I have undergone initial standard treatment for stage IV disease.My kidney, liver, thyroid, and blood tests are all within normal ranges.I agree to use birth control and not donate sperm for 6 months after my last treatment dose.I haven't had any radiotherapy in the last 2 weeks, or 4 weeks if it was for my brain, and I've recovered from any side effects.I am currently being treated for a long-term or active infection.My cancer has spread to my brain or its coverings.I can take care of myself and am up and about more than half of my waking hours.You are able to understand the study and are willing to provide written permission to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1a
- Group 2: Cohort 3
- Group 3: Cohort 4a
- Group 4: Cohort 2b
- Group 5: Cohort 4b
- Group 6: Cohort 2a
- Group 7: Cohort 2c
- Group 8: Cohort 1b
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.
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