Last reviewed · How we verify
NCT06257758
A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors
Phase 1, PHASE2 trial testing VIO-01 in Advanced or Metastatic Solid Tumors in 6 participants. Terminated before completion.
1 January 2025
Quick facts
| Lead sponsor | Valerio Therapeutics |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 10 January 2024 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- VIO-01 — full drug profile →
Conditions studied
- Advanced or Metastatic Solid Tumors — all drugs for Advanced or Metastatic Solid Tumors →
- Breast Cancer — all drugs for Breast Cancer →
- Recurrent Ovarian Cancer — all drugs for Recurrent Ovarian Cancer →
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Valerio Therapeutics — full company profile →
Who can join
18 and older, any sex, with Advanced or Metastatic Solid Tumors or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this phase 1/2 clinical trial is to investigate the safety of an investigational drug called VIO-01 when taken by people who have different types of solid tumor cancers. There are two parts to this trial, part 1 and part 2. Part 1 of the trial aims to answer these questions: * The safety and tolerability of VIO-01 when it is given alone or in combination with other anti-cancer therapies. * The highest dose that people can take without having unacceptable side effects * How well your body tolerates the drug alone or in combination, how they are absorbed, and the effects they have on your disease. Part 2 of the trial will further test VIO-01's effect in participants with advanced HRRm or HRD+ solid tumors and HRRm/HRD+ recurrent ovarian cancer. Participants will follow a schedule of visits to the study site to have assessments done related to their health condition and to receive the trial treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06257758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced or Metastatic Solid Tumors
Currently open trials in the same condition.
- NCT07510828 — PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07205718 — A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07260305 — A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolima · Phase 1 · recruiting
- NCT06548217 — A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
- NCT05957081 — Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 · Phase 1 · recruiting
Other Valerio Therapeutics trials
Trials by the same sponsor.
- NCT05700669 — Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors · Phase 1, PHASE2 · completed
- NCT03579628 — AsiDNA (a DNA Repair Inhibitor) Administered IntraVenously in Advanced Solid Tumors · 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 NCT06257758 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Valerio Therapeutics
- Last refreshed: 17 March 2025
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/NCT06257758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing