Clinical trial · Interventional
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision based on strategic re-alignment
Summary
Brief summary (as posted)
This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor-positive/HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
| SBT6290 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1: SBT6290
- description
- SBT6290 every 3 weeks
- interventionNames
- Drug: SBT6290
- type
- EXPERIMENTAL
- label
- Part 2: SBT6290
- description
- SBT6290 every 3 weeks
- interventionNames
- Drug: SBT6290
- type
- EXPERIMENTAL
- label
- Part 3: SBT6290 + pembrolizumab
- description
- SBT6290 plus pembrolizumab every 3 weeks
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Locally advanced or metastatic solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer) * Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria * Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria * ECOG Performance Status of 0 or 1 * Adequate organ and marrow function Note: Other protocol-defined inclusion/exclusion criteria may apply. Key Exclusion Criteria: * History of allergic reactions to certain components of study treatments * Untreated brain metastases * Currently active (or history of) autoimmune disease * Taking the equivalent of \>10 mg / day of prednisone * Uncontrolled or clinically significant interstitial lung disease (ILD) * History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living * HIV infection, active hepatitis B or hepatitis C infection Note: Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDXu F, Xu K, Fan L, Li X, Liu Y, Yang F, Zhu C, Guan X. Estrogen receptor beta suppresses the androgen receptor oncogenic effects in triple-negative breast cancer. Chin Med J (Engl). 2024 Feb 5;137(3):338-349. doi: 10.1097/CM9.0000000000002930. Epub 2023 Dec 15. PMID 38105538