Urothelial CancerPhase 3NCT07869836
BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy
A Phase 3 study testing T-Bren, Dose level 1, T-bren, Dose level 2 and Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) in people with Urothelial Cancer and Metastatic Urothelial Cancer, run by SystImmune Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, Metastatic Urothelial Cancer, Bladder Cancer
- What is being tested?
- T-Bren, Dose level 1, T-bren, Dose level 2 and Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adequate organ function.
- Adequate coagulation parameters.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Central Georgia Cancer Center
Macon, Georgia, 31210
- Recruiting
Central Georgia Cancer Center
Macon, Georgia, 31210
Mackenzie Sanders, Study Coordinators, 478-743-7068, mackenzie.sanders@aoncology.com
Rachel Warfield, Study Coordinators, 478-743-7068, rachel.warfield@aoncology.com
About this study
Official title: 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
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.
Read the detailed description
This study is a Global Phase 3, randomized, open-label, multicenter study of T-bren for the treatment of metastatic UC. This study will assess the efficacy and safety of T-bren versus PBC in adult participants with HER2-expressing UC after progression on anti-PD-(L)1-based therapy.
- Conditions
- Urothelial Cancer, Metastatic Urothelial Cancer, Bladder Cancer, Bladder Cancer (BC), Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
- Being tested
- T-Bren, Dose level 1, T-bren, Dose level 2, Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)
- Keywords
- Bladder, Urothelial, ADC, T-bren, HER2, Metastatic, Second line, Third line, Targeted Therapy, Antibody drug conjugate
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Bren, Dose level 1Drug
Also called T-Bren, BL-M07D1, Trastuzumab Brengitecan
T-bren: Administered intravenously on day 1 of each 21-day cycle
T-bren, Dose level 2Drug
Also called T-Bren, BL-M07D1, Trastuzumab Brengitecan
TBren administered intravenously on day 1 of each 21-day cycle
Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A, T-bren Dose Level 1 | Experimental | T-bren administered intravenously Receives: Drug: T-Bren, Dose level 1 |
| Arm B, T-bren Dose Level 2 | Experimental | T-bren administered intravenously Receives: Drug: T-bren, Dose level 2 |
| Arm C, Control Arm, Platinum-based Chemotherapy (PBC) | Active comparator | 1. Gemcitabine Administered intravenously
2. Cisplatin or Carboplatin Administered intravenously Receives: Drug: Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) per RECIST v1.1 in the primary population
Measured: Approximately 5 years
Secondary outcomes (9)
Overall Survival (OS)
Overall Survival (OS) in primary population
Measured: Approximately 5 years
Progression-Free Survival (PFS) in the ITT population
Progression-Free Survival (PFS) by BICR per RECIST v1.1 in the ITT (Intent-to-Treat) Population
Measured: Approximately 5 years
Overall Survival (OS) in the ITT population
Measured: Approximately 5 years
Progression-Free Survival (PFS) by Investigator Assessment
Progression-Free Survival (PFS) by Investigator Assessment per RECIST v1.1
Measured: Approximately 5 years
Objective Response Rate (ORR) per RECIST v1.1
Measured: Approximately 5 years
Disease Control Rate (DCR) per RECIST v1.1
Measured: Approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Measured: Approximately 5 years
Time to Response (TTR) per RECIST v1.1
Measured: Approximately 5 years
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SystImmune Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jimmy Liu Zhao, MD, PhD, Study director, SystImmune Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869836
- Sponsor's protocol ID
- BL-M07D1-UC-301
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07869836
- Acronym / sponsor ID
- BL-M07D1-UC-301
- Conditions
- Urothelial Cancer, Metastatic Urothelial Cancer, Bladder Cancer, Bladder Cancer (BC), Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
- Keywords
- Bladder, Urothelial, ADC, T-bren, HER2, Metastatic, Second line, Third line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- SystImmune Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Global Phase 3, randomized, open-label, multicenter study of T-bren for the treatment of metastatic UC. This study will assess the efficacy and safety of T-bren versus PBC in adult participants with HER2-expressing UC after progression on anti-PD-(L)1-based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A, T-bren Dose Level 1 | Experimental | Drug: T-Bren, Dose level 1T-bren administered intravenously |
| Arm B, T-bren Dose Level 2 | Experimental | Drug: T-bren, Dose level 2T-bren administered intravenously |
| Arm C, Control Arm, Platinum-based Chemotherapy (PBC) | Active comparator | Drug: Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)1. Gemcitabine Administered intravenously 2. Cisplatin or Carboplatin Administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Bren, Dose level 1Also: T-Bren, BL-M07D1, Trastuzumab BrengitecanT-bren: Administered intravenously on day 1 of each 21-day cycle | Drug | Arm A, T-bren Dose Level 1 |
| T-bren, Dose level 2Also: T-Bren, BL-M07D1, Trastuzumab BrengitecanTBren administered intravenously on day 1 of each 21-day cycle | Drug | Arm B, T-bren Dose Level 2 |
| 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 | Drug | Arm C, Control Arm, Platinum-based Chemotherapy (PBC) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) per RECIST v1.1 in the primary population
9 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 5 years
Progression-Free Survival (PFS) in the ITT population
Time frame: Approximately 5 years
Overall Survival (OS) in the ITT population
Time frame: Approximately 5 years
Progression-Free Survival (PFS) by Investigator Assessment
Time frame: Approximately 5 years
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Approximately 5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Approximately 5 years
Time to Response (TTR) per RECIST v1.1
Time frame: Approximately 5 years
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jimmy Liu Zhao, MD, PhD study director
SystImmune Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T-Bren, Dose level 1, T-bren, Dose level 2 and Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) in people with Urothelial Cancer and Metastatic Urothelial Cancer, run by SystImmune Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine LaRock (425-453-6841, Christine.LaRock@systimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.