NCT04021277: ACT

PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin

Terminated Phase 1 Last updated 10 October 2024

What this trial tests

Phase 1 trial testing 20 uL/kg PS101 in Solid Tumor in 11 participants. Terminated before completion.

Timeline

17 September 2019

Primary endpoint
27 August 2024

24 September 2024

Quick facts

Lead sponsor	EXACT Therapeutics AS
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	11
Start date	17 September 2019
Primary completion	27 August 2024
Estimated completion	24 September 2024
Sites	4 locations across United Kingdom, Norway

Drugs / interventions tested

• 20 uL/kg PS101 — full drug profile →
• 40 uL/kg PS101 — full drug profile →
• Ultrasound

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

EXACT Therapeutics AS — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Part 1: This clinical study will first test the safety and initial effect on the tumour of PS101-mediated ACT when given in combination with standard of care chemotherapy in patients with liver metastases (initially those with any solid tumors and then further in patients just with colorectal cancer \[CRC\]) in order to identify the recommended dose and schedule of PS101-mediated ACT that can be taken forward for further testing.

Part 2: Based on the Part 1 results, another part in patients with liver metastases from CRC and pancreatic cancer (if indicated) may take place following a substantial protocol amendment.

This record will focus on Part 1 of the study only and will be updated if Part 2 occurs.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liver Immune Microenvironment and Metastasis from Colorectal Cancer-Pathogenesis and Therapeutic Perspectives.
   Zeng X, Ward SE, Zhou J, Cheng ASL. · · 2021 · cited 51× · PMID 34067719 · DOI 10.3390/cancers13102418
2. The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
   Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2
3. Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.
   Bader KB, Padilla F, Haworth KJ, Ellens N, et al · · 2025 · cited 23× · PMID 39526313 · DOI 10.1002/jum.16611
4. Therapeutic Dose Response of Acoustic Cluster Therapy in Combination With Irinotecan for the Treatment of Human Colon Cancer in Mice.
   Bush N, Healey A, Shah A, Box G, et al · · 2019 · cited 11× · PMID 31803049 · DOI 10.3389/fphar.2019.01299
5. Sonosensitive Cavitation Nuclei-A Customisable Platform Technology for Enhanced Therapeutic Delivery.
   Lyons B, Balkaran JPR, Dunn-Lawless D, Lucian V, et al · · 2023 · cited 6× · PMID 38067464 · DOI 10.3390/molecules28237733
6. Submicron-sized ultrasound contrast agents as therapeutic peptide delivery vehicles in type 1 diabetes.
   Ciccaglione M, Abenojar E, Kosmides T, DiLisio JE, et al · · 2026 · PMID 42244978 · DOI 10.7150/thno.126925