Recruiting
Phase 3

T-bren

Sponsor:

SystImmune Inc.

Code:

NCT07869836

Conditions

Urothelial Cancer

Metastatic Urothelial Cancer

Bladder Cancer

Bladder Cancer (BC)

Bladder (Urothelial, Transitional Cell) Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

T-Bren, Dose level 1

T-bren, Dose level 2

Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

Study Details

Brief summary:

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.

Conditions

Urothelial Cancer

Metastatic Urothelial Cancer

Bladder Cancer

Bladder Cancer (BC)

Bladder (Urothelial, Transitional Cell) Cancer

Study ID

NCT07869836

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, <50% overall) are acceptable, provided that TCC is the dominant histology.
  • 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.
  • Adequate coagulation parameters.

Exclusion Criteria:

  • 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.
  • Advanced/clinically significant lung disease (eg, poorly controlled chronic obstructive pulmonary disease or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to randomization.
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) infection.
  • Active hepatitis C virus (HCV) infection.
  • Active or latent tuberculosis.
  • Other protocol-specified inclusion/ exclusion criteria apply

Study Design

Enrollment

520 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A, T-bren Dose Level 1

T-bren administered intravenously

experimental: Arm B, T-bren Dose Level 2

T-bren administered intravenously

active comparator: Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

1. Gemcitabine Administered intravenously
2. Cisplatin or Carboplatin Administered intravenously

Interventions

T-Bren, Dose level 1

T-bren: Administered intravenously on day 1 of each 21-day cycle

T-bren, Dose level 2

TBren administered intravenously on day 1 of each 21-day cycle

Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

Gemcitabine administered intravenously on Day 1 and Day 8 of each 21-day cycle and Cisplatin or Carboplatin administered intravenously on Day 1 of each 21-day cycle

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Approximately 5 years ]

Central Contacts and Locations

Central contacts

Christine LaRock

425-453-6841Christine.LaRock@systimmune.com

Locations

Central Georgia Cancer Center

Recruiting

Macon, Georgia, United States, 31210

Central Georgia Cancer Center

Recruiting

Macon, Georgia, United States, 31210

Contacts

Mackenzie Sanders, Study Coordinators

478-743-7068mackenzie.sanders@aoncology.com

Rachel Warfield, Study Coordinators

478-743-7068rachel.warfield@aoncology.com

Principal Investigator:

Bradley Sumrall, MD

More Information

Sponsor

SystImmune Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Bladder
  • Urothelial
  • ADC
  • T-bren
  • HER2
  • Metastatic
  • Second line
  • Third line
  • Targeted Therapy
  • Antibody drug conjugate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by SystImmune Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.