A Study of Disitamab Vedotin in Subjects With HER2 Expressing Urothelial Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to see if a drug called disitamab vedotin works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen; Seagen Inc.
• Collaborator: RemeGen Co., Ltd.
• Treatments: Trastuzumab

Criteria

Inclusion Criteria:

• Expected survival ≥12 weeks

• Histologically confirmed locally advanced unresectable or metastatic urothelial cancer (UC), including UC originating from the renal pelvis, ureters, bladder, or urethra

• Participant has received 1 or 2 lines of prior treatment for advanced UC, including 1 line of platinum-containing chemotherapy

• Neoadjuvant or adjuvant therapy, with progression within 12 months of completing therapy, is considered a line of prior therapy.

• Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate line of therapy.

• Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first line maintenance therapy or as second line treatment are allowed

• Radiographically documented disease progression during or after the most recent line of therapy for advanced disease

• At least one measurable lesion based on RECIST version 1.1.

• HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the most recent archival or fresh tumor sample

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Known hypersensitivity to disitamab vedotin or any of its components

• Prior anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 3 weeks of start of study

• Toxicity from a previous treatment has not returned to Grade 0-1 (except for Grade 2 alopecia)

• Prior MMAE-based ADCs (eg enfortumab vedotin) or HER2-directed therapy

• Major surgery that has not fully recovered within 4 weeks prior to dose administration

• Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

• Other malignant tumors within 5 years of study treatment, except for:

• Prostate cancer treated with definitive intent (surgically or with radiation therapy) at ≥ 1 year prior to treatment initiation is acceptable

• Malignancies that can be cured after treatment

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.