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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

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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Other study objectives

Assess shedding and viremia of VSV-GP128

Biopsy

Evaluate pharmacodynamic effects of study treatment

+1 more

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

~520

0 / 36Eligibility criteria met

Find a Location

Who is running the clinical trial?

Amal TherapeuticsLead Sponsor

1 Previous Clinical Trials

85 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,534 Previous Clinical Trials

11,357,431 Total Patients Enrolled

Scott KopetzPrincipal InvestigatorMD Anderson

1 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

ATP128 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04046445 — Phase 1

Colorectal Cancer Research Study Groups: Cohort 1a, Cohort 3, Cohort 4a, Cohort 2b, Cohort 4b, Cohort 2a, Cohort 2c, Cohort 1b

Colorectal Cancer Clinical Trial 2023: ATP128 Highlights & Side Effects. Trial Name: NCT04046445 — Phase 1

ATP128 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046445 — Phase 1

~16 spots leftby Sep 2025

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