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

NCT04021277 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-10-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

20 uL/kg PS101

20 uL/kg PS101 and chemotherapy given for 4 cycles over 6 weeks

DRUG

40 uL/kg PS101

40 uL/kg PS101 and chemotherapy given for 4 cycles over 6 weeks

DEVICE

Ultrasound

Ultrasound activation and enhancement

Sponsors & Collaborators

  • EXACT Therapeutics AS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2024-08-27
Completion
2024-09-24

Countries

  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021277 on ClinicalTrials.gov