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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2030-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-muscle Invasive Bladder Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase I: Dose Escalation

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.

Group Type EXPERIMENTAL

Eciskafusp Alfa

Intervention Type DRUG

Participants will receive eciskafusp alfa via intravesical instillation.

BCG Medac Strain

Intervention Type DRUG

Participants will receive BCG via intravesical instillation.

Phase II: Dose Extension (Cohort A)

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.

Group Type EXPERIMENTAL

Eciskafusp Alfa

Intervention Type DRUG

Participants will receive eciskafusp alfa via intravesical instillation.

BCG Medac Strain

Intervention Type DRUG

Participants will receive BCG via intravesical instillation.

Phase II: Dose Extension (Cohort B)

Participants will receive eciskafusp alfa as monotherapy at the MTD or RDE determined in Phase 1, 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.

Group Type EXPERIMENTAL

Eciskafusp Alfa

Intervention Type DRUG

Participants will receive eciskafusp alfa via intravesical instillation.

Interventions

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Eciskafusp Alfa

Participants will receive eciskafusp alfa via intravesical instillation.

Intervention Type DRUG

BCG Medac Strain

Participants will receive BCG via intravesical instillation.

Intervention Type DRUG

Other Intervention Names

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RO7284755

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No