Clinical trial · Interventional
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2
NCT04460456CI-TRIAL-00059403unknownPhase 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)
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
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 |
|---|---|---|---|
| HER2 Positive Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cemiplimab | Drug | Cemiplimab | ALIAS |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
| SBT6050 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SBT6050 Monotherapy
- description
- Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
- interventionNames
- Drug: SBT6050
- type
- EXPERIMENTAL
- label
- SBT6050 and pembrolizumab
- description
- Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.
- interventionNames
- Drug: SBT6050
- Drug: pembrolizumab
- type
- EXPERIMENTAL
- label
- SBT6050 and cemiplimab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor * Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive) * Measurable disease per RECIST 1.1 * Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, hepatic, and cardiac function Exclusion Criteria: * History of allergic reactions to certain components of SBT6050 or similar drugs * Untreated brain metastases * Active autoimmune disease or a documented history of autoimmune disease or syndrome * Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection * Additional protocol defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.