ATP128 + VSV-GP128 + BI 754091 for Colorectal Cancer

(KISIMA-01 Trial)

Recruiting at11 trial locations

Overseen by Scott Kopetz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Amal Therapeutics

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128. The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations: * Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies * Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum) * Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease: * Patients in Cohort 1a will receive ATP128 as single agent * Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091 * Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091

Research Team

Scott Kopetz

Principal Investigator

MD Anderson

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have or had hepatitis B or C.

My heart health does not meet the specific criteria listed, including issues with my heart's rhythm or a low ejection fraction.

I am not allergic to any of the drugs or their components used in this study.

Treatment Details

Interventions

• ATP128 (Cancer Vaccine)
• BI 754091 (PD-1 Inhibitor)
• VSV-GP128 (Virus Therapy)

Trial Overview 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.

Participant Groups

Group I: Cohort 4b Experimental Treatment 3 Interventions

15 patients with stage IV MSS/MMRp CRC with liver-limited disease

Group II: Cohort 4a Experimental Treatment 3 Interventions

24 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC

Group III: Cohort 3 Experimental Treatment 3 Interventions

6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC

Group IV: Cohort 2c Experimental Treatment 2 Interventions

19 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC

Group V: Cohort 2b Experimental Treatment 2 Interventions

15 patients with stage IV MSS/MMRp CRC with liver-limited disease

Group VI: Cohort 2a Experimental Treatment 2 Interventions

5 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC

Group VII: Cohort 1b Experimental Treatment 2 Interventions

6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC

Group VIII: Cohort 1a Experimental Treatment 1 Intervention

6 patients with stage IV CRC who failed SoC therapies

Who Is Running the Clinical Trial?

Amal Therapeutics

Lead Sponsor

Trials

2

Recruited

180+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+