clinical trial · NCT06816017
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)
Hoffmann-La Roche·phase1·withdrawn
Non-muscle Invasive Bladder CancerEciskafusp AlfaBCG Medac Strain
brief summary
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.
started
Jun 15, 2025
primary completion
Oct 31, 2028
completion
Oct 31, 2030
last updated
Jun 16, 2025
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol