A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: SGNB6A-001
  • Secondary ID: N/A
  • NCT ID: NCT04389632
  • Sponsor: Seagen Inc.

BRIEF SUMMARY

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

* Part A of the study will find out how much sigvotatug vedotin should be given to participants.
* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
* In Parts C and D, participants will receive sigvotatug vedotin with either:

* Pembrolizumab or,
* Pembrolizumab and carboplatin, or
* Pembrolizumab and cisplatin.

  • Overall Status
    Recruiting
  • Start Date
    June 8, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Carcinoma
  • Non-Small Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • HER2 Negative Breast Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Ovarian Neoplasms
  • Cutaneous Squamous Cell Cancer
  • Exocrine Pancreatic Adenocarcinoma
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
  • Stomach Neoplasms

ELIGIBILITY

Inclusion Criteria:
* Disease indication
* Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).
* Non-small cell lung cancer (NSCLC)

- * Head and neck squamous cell cancer (HNSCC)

- * Advanced HER2-negative breast cancer

- * Esophageal squamous cell carcinoma (ESCC)

- * Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)

- * Cutaneous squamous cell cancer (cSCC)

- * Exocrine pancreatic adenocarcinoma

- * Bladder cancer

- * Cervical cancer

- * Gastric cancer

- * High grade serous ovarian cancer (HGSOC)

- * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.

- * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if applicable and available.

- * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab monotherapy per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care.

- * Part D only: Participants must be treatment naive for locally advanced or metastatic systemic therapy (prior definitively intended or adjuvant therapy is allowed with the exception of PD-[L]1 inhibitors).

- * Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:
* Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days may be used.

- * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy

- * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- * Measurable disease per the RECIST v1.1 at baseline
Exclusion Criteria
* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.

- * Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
* are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,

- * have no new or enlarging brain metastases, and

- * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.

- * Carcinomatous meningitis

- * Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6

- * Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts

- * Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.
* Routine antimicrobial prophylaxis is permitted

- * Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses

- * Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).

- * History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening

- * Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) <50% predicted

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Scott Knowles, MD, PhD

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: Florida Cancer Specialists - Lake Nona
Orlando, Florida 32827
United States
Status: Recruiting Contact: Contact
Ingrid Acker
689-216-8500

Principal Investigator
Cesar Perez Batista, MD

Facility: Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Alisa Posner
617-975-7423
aposner1@bidmc.harvard.edu

Principal Investigator
Bruno Bockorny, MD

Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Illya Dixon
617-632-5084
Illya_Dixon@dfci.harvard.edu

Principal Investigator
Kartik Sehgal

Facility: Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Status: Recruiting Contact: Contact
Edwin C Kingsley
702-952-3400
edwin.kingsley@usoncology.com

Principal Investigator
Edwin C Kingsley

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Megan Boland
216-286-3369
Megan.Boland@UHhospitals.org

Principal Investigator
Afshin Dowlati

Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Providence Cancer Institute CT.Gov Contact
503-215-2614
CanClinRsrchStudies@providence.org

Principal Investigator
Rachel E Sanborn

Facility: Providence Portland Medical Center
Portland, Oregon 97225
United States
Status: Recruiting Contact: Principal Investigator
Rachel E Sanborn

Facility: Sanford Cancer Center
Sioux Falls, South Dakota 57104
United States
Status: Recruiting Contact: Contact
Staci Vogel
605-328-8000
Staci.Vogel@sanfordhealth.org

Principal Investigator
Steven Powell

Facility: MD Anderson Cancer Center / University of Texas
Houston, Texas 77030-4095
United States
Status: Recruiting Contact: Contact
Rabia Khan
713-745-4667
RKhan@mdanderson.org

Principal Investigator
Sarina A Piha-Paul

Facility: South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Isabel Jimenez
210-593-5265
isabel.jimenez@startsa.com

Principal Investigator
Amita Patnaik

Facility: Vista Oncology Inc PS
Olympia, Washington 98506
United States
Status: Recruiting Contact: Contact
Yiqun (Lydia) Xue
360-810-3619
yiqun.xue@aoncology.com

Principal Investigator
Joseph Z Ye