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Cola

6 patients with stage IV CRC who failed SoC therapies

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

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

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

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

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

ATP128

BI 754091

VSV-GP128

Scott Kopetz

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

Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

Immune-monitoring based on blood and tissue samples

Monitoring of ctDNA detection in the plasma

Based on immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Based on PCR and TCID50 in biological fluids

Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Based on evaluation of AEs with the support of pharmacodynamics

Spots Global Cancer Trial Database for atp128

Every month we try and update this database with for atp128 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for atp128

Every month we try and update this database with for atp128 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for atp128 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.