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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) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

INTRODUCTION

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

DESCRIPTION

To read more about what this clinical trial is about please click this link:

RC48G001_PFM_PatientTrialCard_US_ENG_V1.0_30Aug2022_USM_DV_2022_0018

 

BRIEF SUMMARY

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, 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 3, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
Cohorts A and B
* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra

- * Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy

- * At least one measurable lesion by investigator assessment based on RECIST version 1.1.

- * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

- * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Cohort C
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

- * No prior systemic therapy for LA/mUC
* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy

- * At least one measurable lesion by investigator assessment based on RECIST v1.1.

- * Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation

- * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample

- * ECOG performance status of 0, 1, or 2
Cohort D
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

- * Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:
* a. One prior line of platinum-containing chemotherapy.

- * b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.

- * c. Prior enfortumab vedotin therapy.

- * At least one measurable lesion by investigator assessment based on RECIST v1.1.

- * ECOG performance status of 0 or 1
Cohort E
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

- * No prior systemic therapy for LA/mUC
* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.

- * At least one measurable lesion by investigator assessment based on RECIST v1.1.

- * Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation

- * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

- * ECOG performance status of 0 or 1
Exclusion Criteria:
Cohorts A and B
* Known hypersensitivity to disitamab vedotin or any of their components

- * Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)

- * Toxicity from a previous treatment has not returned to Grades 0 or 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
Cohort C
* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components

- * Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)

- * Toxicity from a previous treatment has not returned to Grades 0 or 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

- * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

- * Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.
Cohort D
* Known hypersensitivity to disitamab vedotin or any of their components

- * Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)

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

- * Prior HER2-directed therapy

- * Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy

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

- * Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
Cohort E
* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components

- * Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)

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

- * Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy

- * 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 1 at baseline

- * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
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: Seagen Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Isaac Bowman

Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Abhishek Tripathi

Facility: University of California Los Angeles Medical Center
Los Angeles, California 90095
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Alexandra Drakaki

Facility: University of California Irvine Medical Center
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Nataliya Mar

Facility: Kaiser Permanente Southern California
Riverside, California 92505
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Helen Moon

Facility: University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California 94158
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Vadim Koshkin

Facility: University of Colorado Health Memorial Hospital
Colorado Springs, Colorado 80909
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Facility: Florida Cancer Specialists - South Region
Fort Myers, Florida 33901
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Amir Harandi

Facility: Florida Cancer Specialists - Panhandle
Tallahassee, Florida 32308
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Pareshkumar Patel

Facility: H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Rohit Jain

Facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
West Palm Beach, Florida 33401
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Barry Berman

Facility: Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia 30060
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Steve McCune

Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Peter H O'Donnell

Facility: Henry Ford Health System
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Clara Hwang

Facility: Karmanos Cancer Institute / Wayne State University
Detroit, Michigan 48226
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Elisabeth Heath

Facility: Cancer and Hematology Centers of Western Michigan / Spectrum Health Butterworth Campus
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Eric Batts, MD

Facility: Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Oscar B Goodman Jr.

Facility: North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Thomas P Bradley

Facility: Mount Sinai Medical Center
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Matthew Galsky

Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Gopakumar Iyer

Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Earle Burgess

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Jason Robert Brown

Facility: Oregon Health and Science University
Portland, Oregon 97239
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Facility: University of Tennessee
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Saikrishna Gadde

Facility: MD Anderson Cancer Center / University of Texas
Houston, Texas 77030-4095
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Matthew T Campbell

Facility: Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Jeanny B Aragon-Ching, MD, F.A.C.P.

Facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Evan Yu

Facility: Medical College of Wisconsin (Milwaukee)
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Principal Investigator
Ariel Nelson