RecruitingPhase 3interventionalRules rewrite

Phase 3: testing T-Bren, Dose level 1 for Urothelial Cancer

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

Official registry: https://clinicaltrials.gov/study/NCT07869836 · SystImmune Inc. · enrollment listed as 520

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are T-Bren, Dose level 1, T-bren, Dose level 2, or Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin). The registry lists allocation as randomized. The objective of the study is to measure the how well it works and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.

They plan to enroll about 520 people at Macon. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy

Interventions: T-Bren, Dose level 1, T-bren, Dose level 2, Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

Primary outcome (registry wording): Progression-Free Survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Disease progression or recurrence during or following anti-PD-(L)1-based therapy
Fresh biopsy or archival tumor samples
Documented HER2 expression by central laboratory testing
Eligible to receive carboplatin or cisplatin in combination with gemcitabine
At least 1 measurable lesion based on RECIST v1.1
An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
Adequate organ function

Who the registry excludes

Prior topoisomerase inhibitor-based ADC therapy
Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis
Bladder cancers with small cell histology
Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years
Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization
Active autoimmune diseases and inflammatory diseases
History of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening

Public study contact (from the registry)

Christine LaRock

425-453-6841

Christine.LaRock@systimmune.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Central Georgia Cancer Center — Macon, Georgia (recruiting)

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FAQ about this NCT record

Is NCT07869836 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07869836?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07869836?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary