ACT plus Chemotherapy in Liver Metastases

• Research type

  Research Study

• Full title

  A Phase I Trial Investigating The Combination Of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy For The Treatment Of Liver Metastasis In Patients With Solid Tumours With An Expansion Cohort In Metastatic Colorectal And Pancreatic Cancer

• IRAS ID

  256261

• Contact name

  Udai Banerji

• Contact email

  udai.banerji@icr.ac.uk

• Sponsor organisation

  EXACT Therapeutics AS

• Eudract number

  2018-004609-16

• Clinicaltrials.gov Identifier

  NCT04021277

• Duration of Study in the UK

  6 years, 3 months, 13 days

• Research summary

  The less than optimal delivery of an anticancer agent to cancer cells is a problem that spans virtually all solid tumours. If it were possible to increase the amount of drug that reached any tumour, without changing the amount administered, then it should be possible to improve the efficacy of the anticancer therapy without increasing the side effects.
  Acoustic Cluster Therapy (ACT) is a procedure of combining a novel agent PS101 with the administration of an anticancer drug and application of localised ultrasound in order to increase the access of the anticancer drug to a tumour.
  This is a two part Phase I dose escalation and dose finding study of PS101-mediated ACT combined with standard of care chemotherapy for the treatment of liver metastasis in patients with advanced solid tumours with an expansion part in CRC and PDAC patients.
  The PS101-medicated ACT treatment consists of a product PS101 that when activated by targeted ultrasound increases the permeability of the tumour vasculature being subjected to ultrasound enabling the passage of chemotherapy into the cells.
  The patient will be on study for up to four cycles of chemotherapy and PS101-mediated ACT over up to six weeks, followed by a safety follow-up at week 12.After completion of the study treatment, patients may continue on the same chemotherapy without ACT treatment according to their local standard of care.
  Tumour response is measured by CT scan at baseline and every eight weeks thereafter until progression or week 24 whichever occurs first. MRI scans may also be undertaken.
  Up to 4 UK sites will be involved in Part 1 and 2 (Royal Marsden NHS Trust Hospital, The Freeman Hospital of Newcastle and 1-2 sites to be defined).
  A total of up to 63 patients will be recruited into the trial.

  Lay summary of study results:

  Among patients who responded to chemotherapy, tumour shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals.

  ACT treatment, using the investigational medicine PS101, had a clear dose-response relationship. Tumour shrinkage was significantly greater in patients who received the highest of the two PS101 doses tested. Tumour shrinkage was seen in 6 out of 9 patients who received ACT with chemotherapy. PS101 was safe and well tolerated when given with chemotherapy.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Phase I study
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Poster presentation at AACR Annual Conference, 5 April 2024 (trial in progress), Abstract #6221: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Faacrjournals.org%252Fcancerres%252Farticle%252F84%252F6_Supplement%252F6221%252F736430%252FAbstract-6221-First-in-human-study-of-acoustic%253Fsearchresult%253D1%2FNBTI%2FxKK-AQ%2FAQ%2Fd7e1bc6f-0e42-4af4-961a-1c94756c296c%2F1%2FlD8mf1q8Pm&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C126f355a39e2414692d108dde54d9c4f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638918843696331544%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=PlbXbtZPaJgP85lhRwDsEhFCNnD4%2BUGPM6pcAvsnJKw%3D&reserved=0

  On company website:
  20 May 2025: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fexact-tx.com%252Fnews-page%252Fexact-therapeutics-announces-positive-final-results-in-phase-1-activate-trial-in-liver-metastases-from-colorectal-cancer%2FNBTI%2FxKK-AQ%2FAQ%2Fd7e1bc6f-0e42-4af4-961a-1c94756c296c%2F2%2FxTFJkmDcKx&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C126f355a39e2414692d108dde54d9c4f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638918843696374402%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Xa48oqKn1ybcfiEKRayvGz%2FIZHdv5%2FbSkE2bmmtavvM%3D&reserved=0
  25 April 2024: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fexact-tx.com%252Fnews-page%252Fexact-therapeutics-presented-poster-at-american-association-for-cancer-research%2FNBTI%2FxKK-AQ%2FAQ%2Fd7e1bc6f-0e42-4af4-961a-1c94756c296c%2F3%2FjoVL67Nhg9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C126f355a39e2414692d108dde54d9c4f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638918843696414753%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=RY34ezKcMvu%2BGgtt4j%2BlInMiH3M9U7cNZTtEWzoAYt0%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: No
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't: Information has been made available in the public domain.
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Phase I study
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No tissue samples were stored.
  Captcha: 0cAFcWeA5pCp4ntKsBxP_XO0uH6YwM3QmStW2gtR864b2SLPnp4WdCPwVHHCEnBUYUf_0plAqnPEgOs5tbaXlbJg0BEVIO6gypNsXj8cBRgPHfZzfL0A_yOEntBqLH4cz4m9SEdkDvl2-wb31obabdsKhYqVwtb9yPG8kL2AAfp3-VvMyt6hHilCfbknX9FfX-ra-OR888s-mzMFM--stkdD8gnYdFT9aNCChPM7h1TJ6VPcLTWyu8rAZ2hNQsZlJRORVqtTczuU3Ep9zj1_MVKwemj-wBI4yaPLkEx8vNrZUCN1al_2i7I0dIK90GKqTCaW6PyXYB2M20A8v8iSgmPlT8Rw8-IEvA6pkJ1cwRlRSVLLV6zPsuCsz3VmsCQ_UgtuqE8qH5lIzGUaY5W8o86zbOYtJePh1XDoXOQ-6THLOoGmjagqleBpxn0ePoBKUOsFd7Zec44H3LvlFi0Qzw4vzPCEhLSKFmPKPZ8OETn-u4HLNQ8JdUqPL7Xu744hELbArW2C2jSBo8SIl7h0g_O24Vbrfz9YOsqyiwXNWxg2NqoL2I8qXS-L1TvPgc0_emBVBLauTy-QDroUM32XjXh5u7QgR5vjAOVleIFTz2-AB6L3ksEyftLHLidWljSvTeCUGEiKd96brgM_fOhV02YGY_XCAzUhIEdujmJX5YMzBZH7WAmUsU0xmnQlDtsIJNOzK6HoD7n0mqM9fC0gXU7wxyRoIWsdFlv5WSY7SL-rp_7r17Ne5H3PJlwfDONW8V8fvLBQTVj0TaTwmGdKaMLsdjoIG6kQTPsw
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  19/LO/0213

• Date of REC Opinion

  2 Apr 2019

• REC opinion

  Favourable Opinion