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Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer

ConditionMuscle-Invasive Bladder Cancer (MIBC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarbin Medical University

About this trial

This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

ECOG performance status of 0 or 1.

Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).

Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).

Disqualifiers

Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.

Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks before the first dose.

History of severe allergic reactions to other monoclonal antibodies.

Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose >10 mg/day prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trastuzumab Rezetecan Combined with Adebelizumab

    Drug

    Trastuzumab Rezetecan 3.2 mg/kg, Q3W, in combination with Adebrelimab 1200 mg, Q3W, for a total of 3 cycles. Subjects will undergo preoperative imaging and surgical eligibility assessment at 3-4 weeks after the last dose of neoadjuvant therapy. Those who meet the surgical criteria will receive either transurethral resection or radical resection.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological Complete Response

Assessed by pathological evaluation of resected bladder cancer specimens after neoadjuvant therapy, defined as the proportion of patients with no residual tumor (pT0N0).

Time frame
Assessed post-surgery (radical cystectomy or TURBT) on resected tumor specimens after neoadjuvant therapy. Measured postoperatively, up to approximately 4 months after treatment start.

Secondary outcomes

1

Clinical Complete Response Rate

Assessed by preoperative imaging (CT/MRI) and urine cytology after neoadjuvant therapy, defined as the proportion of patients with no residual tumor on imaging, negative urine cytology, and no evidence of nodal or distant metastasis.

Time frame
Assessed by preoperative imaging and surgical evaluation at 3-4 weeks after the last neoadjuvant dose. Up to approximately 4 months after treatment start.
2

Pathological Downstaging Rate

Assessed by postoperative pathological staging, defined as the proportion of patients with ypT \< T2 and ypN = N0 after neoadjuvant therapy.

Time frame
Assessed simultaneously with pCR on postoperative pathological staging. Up to approximately 4 months after treatment start.
3

Event-Free Survival

Time from first dose to first occurrence of disease progression, recurrence, second primary tumor, or death from any cause.

Time frame
Time from treatment start to first occurrence of disease progression, recurrence, second primary tumor, or death. Continuously assessed during follow-up, maximum follow-up of 36 months.
4

Overall Survival

Time from first dose to death from any cause.

Time frame
Time from treatment start to death from any cause. Continuously assessed, maximum follow-up of 36 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harbin Medical University

Lead sponsor

The Fourth Affiliated Hospital of China Medical University

Collaborator

Jilin Provincial Tumor Hospital

Collaborator

Tianjin Medical University Second Hospital

Collaborator

First Hospital of China Medical University

Collaborator

Source ClinicalTrials.gov

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