Last reviewed · How we verify
NCT04891718
CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
EARLY_PHASE1 trial testing MVC-101 in Solid Tumour. Withdrawn.
5 June 2022
Quick facts
| Lead sponsor | Presage Biosciences |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Start date | 15 September 2021 |
| Primary completion | 5 June 2022 |
| Estimated completion | 5 June 2022 |
| Sites | 3 locations across Australia |
Drugs / interventions tested
Conditions studied
- Solid Tumour — all drugs for Solid Tumour →
Sponsor
Presage Biosciences — full company profile →
Who can join
18 and older, any sex, with Solid Tumour. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in microdose quantities via the CIVO device in patients with surface accessible solid tumours for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Rational Combinations of Targeted Therapy and Immune Checkpoint Inhibitors in Head and Neck Cancers.
Chai AWY, Yee PS, Cheong SC. · · 2022 · cited 6× · PMID 35372020 · DOI 10.3389/fonc.2022.837835
Verify or expand the search:
- PubMed search for NCT04891718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumour
Currently open trials in the same condition.
- NCT06883539 — A Phase I Study of LXP1788 Injection with Advanced Solid Tumors. · Phase 1 · recruiting
- NCT06551051 — ADC-induced Neurotoxicity Treated With Duloxetine · Phase 2 · recruiting
Other Presage Biosciences trials
Trials by the same sponsor.
- NCT06413095 — PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in · EARLY_PHASE1 · completed
- NCT04272333 — Intratumoral Microdosing of Motolimod in HNSCC · EARLY_PHASE1 · terminated
- NCT06062602 — PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC · EARLY_PHASE1 · completed
- NCT04065555 — Intratumoral Microdosing of TAK-981 in Head and Neck Cancer · EARLY_PHASE1 · completed
- NCT03056599 — Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04891718 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Presage Biosciences
- Last refreshed: 8 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04891718.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing