Clinical trial · Interventional
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase I/II, Open-label, Dose Escalation and Extension Study of Intravesical Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
NCT06816017CI-TRIAL-00091070withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision of the Sponsor.
Summary
Brief summary (as posted)
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with BCG in participants with BCG-unresponsive high-risk NMIBC. The study plans a similar evaluation of eciskafusp alfa in monotherapy following a positive interim analysis of the combination therapy.
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 |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG Medac Strain | Drug | — | UNRESOLVED |
| Eciskafusp Alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I: Dose Escalation
- description
- Participants will receive multiple ascending doses of eciskafusp alfa in combination with a fixed dose of BCG administered as an intravesicular instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.
- interventionNames
- Drug: Eciskafusp Alfa
- Drug: BCG Medac Strain
- type
- EXPERIMENTAL
- label
- Phase II: Dose Extension (Cohort A)
- description
- Participants will receive eciskafusp alfa at the maximum tolerated dose (MTD) and/or the recommended dose for extension (RDE), as determined in Phase 1, in combination with a fixed dose of BCG administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first.
- interventionNames
- Drug: Eciskafusp Alfa
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system * Absence of resectable disease after transurethral resection of bladder tumor (TURBT) procedures * The most recent cystoscopy/TURBT must have been performed within 12 weeks and up to 14 days of the first dose of study treatment * Presence of BCG-unresponsive disease defined as persistent or recurrent carcinoma in situ \[CIS\] (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy * The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure. * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening * Negative hepatitis C virus (HCV) antibody test at screening Exclusion Criteria: * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders * Active infections (both systemic and local urinary) * Congenital or acquired immune deficiencies resulting in immunosuppression * Known human immunodeficiency virus (HIV) infection * History of radiotherapy of the bladder * History of perforation of the bladder * Major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment * Participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, and supportive care therapies for active disease * Any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/TURBT to the start of study treatment * Systemic immune-modulating and systemic immunosuppressive agents/medication * Administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment * Recurrence of BCG unresponsive CIS \> 12 months after last BCG instillation * Concurrent second malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.