Clinical trial · Interventional
Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors
Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Efficacy of VB15010 Tablets In Patients With Advanced Solid Tumors
NCT06819215CI-TRIAL-00085802recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| PARP | — | UNRESOLVED | — |
| Prostatic Cancer | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VB15010 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- VB15010 Monotherapy
- interventionNames
- Drug: VB15010
Primary outcomes (2)
- measure
- The number of subjects with adverse events/serious adverse events
- timeFrame
- From time of Informed Consent to 30+7 days post last dose
- description
- Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
- measure
- The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
- timeFrame
- At the end of Cycle 1(each cycle is 28 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 at the time of screening; * Histological or cytological confirmation of advanced malignancy ; * Progressive cancer at the time of study entry; * Adequate organ and marrow function as defined by the protocol; * Homologous recombination repair gene mutation. Exclusion Criteria: * Major surgery within 4 weeks of the first dose of study treatment. * Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \>10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded. * Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
References
Publications (0)
Data not yet available
No reference posted for this study.