Clinical trial · Interventional
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors
NCT07042100CI-TRIAL-00119610recruitingPhase 1ClinicalTrials.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 is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DL2 | Biological | — | UNRESOLVED |
| DL3 | Biological | — | UNRESOLVED |
| DL4 | Biological | — | UNRESOLVED |
| DL5 | Biological | — | UNRESOLVED |
| Dose level (DL)1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBO-154
- interventionNames
- Biological: Dose level (DL)1
- Biological: DL2
- Biological: DL3
- Biological: DL4
- Biological: DL5
Primary outcomes (3)
- measure
- Incidence of dose-limiting toxicities
- timeFrame
- Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)
- description
- Applicable to Part 1 only
- measure
- Incidence of treatment-related serious adverse events
- timeFrame
- Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willing and able to give written and dated informed consent (or legally acceptable representative/ impartial witness when applicable) and is available for the entire study. 2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up. 3. Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no standard treatment is available. 4. Has a life expectancy of ≥3 months. Exclusion Criteria: 1. Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration. 2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination. 3. Known or suspected history of significant drug abuse as judged by the Investigator. 4. Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. 5. Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry. 6. Positive exclusion tests: urine pregnancy tests (if applicable), serology tests positive for HIV, HCV, HBsAg (unless they are considered subjects with resolved Hepatitis B and C infection). 7. History of any relevant allergy/ hypersensitivity including known immediate or delayed hypersensitivity reaction or idiosyncrasy to biological agents or drug chemically related to SBO-154 or its excipients. 8. Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.
References
Publications (0)
Data not yet available
No reference posted for this study.