A Study of RC48-ADC in Patients With HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma

Brief Title

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

Official Title

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 cORR per RECIST v1.1 by investigator assessment

Condition

Urothelial Carcinoma

Intervention

Disitamab vedotin

Study Arms / Comparison Groups

 Disitamab vedotin

Description:  Disitamab vedotin monotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 31, 2022

Completion Date

November 30, 2025

Primary Completion Date

May 31, 2025

Eligibility 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xuemei Li, MD, 866-333-7436, [email protected]

Administrative Informations

NCT ID

NCT04879329

Organization ID

RC48 G001

Responsible Party

Sponsor

Study Sponsor

Seagen Inc.

Collaborators

 RemeGen Co., Ltd.

Study Sponsor

Xuemei Li, MD, Study Director, Seagen Inc.

Verification Date

October 2021