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520 Participants NeededMy employer runs this trial

T-bren vs Chemotherapy for Bladder Cancer

CL
Overseen ByChristine LaRock
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: SystImmune Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of the study is to evaluate the efficacy and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.

Who Is on the Research Team?

JL

Jimmy Liu Zhao, MD, PhD

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

This trial is for adults with metastatic urothelial (bladder) cancer that shows HER2 protein and has gotten worse after treatment with anti-PD-(L)1 immunotherapy. Participants should be in generally good health aside from their cancer.

Inclusion Criteria

At least 1 measurable lesion based on RECIST v1.1
My organs are working well enough for treatment.
Adequate coagulation parameters
See 6 more

Exclusion Criteria

I have an active autoimmune or inflammatory disease.
I currently have an active hepatitis B infection.
Other protocol-specified inclusion/exclusion criteria apply
See 10 more

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)
  • T-bren (Trastuzumab Brengitecan)

Trial Overview

The study compares a new drug called T-bren (Trastuzumab Brengitecan), given at two different doses, to standard chemotherapy using gemcitabine plus either cisplatin or carboplatin. Patients are randomly assigned to one of these treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B, T-bren Dose Level 2Experimental Treatment1 Intervention
Group II: Arm A, T-bren Dose Level 1Experimental Treatment1 Intervention
Group III: Arm C, Control Arm, Platinum-based Chemotherapy (PBC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials
23
Recruited
1,800+

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