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

Summary

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.

Timeline

Start

2019-09-17

Primary completion

2024-08-27

Completion

2024-09-24

Outcome

Met primary endpoint

Stopped (Business): “Business reason”

release “ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p<0.05)” exact-tx.com ↗

Publications

• Fan CH, Ho YJ, Lin CW, Wu N, Chiang PH, Yeh CK. State-of-the-art of ultrasound-triggered drug delivery from ultrasound-responsive drug carriers. Expert Opin Drug Deliv. 2022 Aug;19(8):997-1009. doi: 10.1080/17425247.2022.2110585. Epub 2022 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PS101	Unknown	20 unknown	Intravenous
Subject	PS101	Unknown	40 unknown	Intravenous

Indications