Clinical trial · Interventional
A Study in Patients With Advanced Cancers
A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
NCT05320588CI-TRIAL-00059724recruitingPhase 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)
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Conditions
Conditions (4)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIO-106 | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single agent BIO-106
- description
- Escalating doses followed by expansion targeting advanced cancers
- interventionNames
- Drug: BIO-106
- type
- EXPERIMENTAL
- label
- Combination BIO-106 plus pembrolizumab
- description
- Escalating doses followed by expansion targeting advanced cancers
- interventionNames
- Drug: BIO-106
- Drug: Pembrolizumab
Primary outcomes (4)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients histologically or cytologically documented, locally advanced or metastatic solid tumor. * Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment. * Measurable disease as determined by RECIST v.1.1 or bone only disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: * History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody. Impaired cardiac function or history of clinically significant cardiac disease * Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. * Active SARS-CoV-2 infection. * Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis. Other protocol defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.