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Brief Title: Disitamab Vedotin in Subjects With HER2 Expressing Urothelial Carcinoma

A Phase 2 Multi Cohort, Open Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48 ADC) in Subjects With HER2 Expressing Locally Advanced Unresectable or Metastatic Urothelial Carcinoma

INTRODUCTION

  • Org Study ID: RC48G001
  • Secondary ID: N/A
  • NTC ID: NCT04879329
  • Sponsor: Seagen Inc.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    May 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by independent central review (ICR)

Primary Outcome 1 - Timeframe: Duration of treatment; approximately 2 years

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Kevin Sokolowski, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Kevin Sokolowski, MD

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact