A Study of SGN-B6A in Advanced Solid Tumors

April 12, 2024 updated by: Seagen Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

824

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Other
      • Villejuif Cedex, Other, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Antoine Hollebecque
  • Spain
    • Other
      • Barcelona, Other, Spain, 08023
        • Recruiting
        • Hospital Hm Nou Delfos
        • Principal Investigator:
          • Tatiana Carolina Hernandez Guerrero
      • Barcelona, Other, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Elena Garralda Cabanas
      • Jerez de la Frontera, Other, Spain, 11407
        • Recruiting
        • Hospital Universitario De Jerez
        • Principal Investigator:
          • Jesus Corral
      • Madrid, Other, Spain, 28050
        • Recruiting
        • START Madrid-CIOCC_Hospital HM Sanchinarro
        • Principal Investigator:
          • Emiliano Calvo
      • Madrid, Other, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
        • Principal Investigator:
          • Federico Longo
      • Santander, Other, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Principal Investigator:
          • Fernando Rivera Herrero
  • Switzerland
    • Other
      • Lausanne, Other, Switzerland, 1011
        • Recruiting
        • University Hospital Lausanne CHUV
        • Principal Investigator:
          • Solange Peters
  • United Kingdom
    • Other
      • London, Other, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute UK
        • Principal Investigator:
          • Elisa Fontana
      • Sutton, Other, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden Hospital (Surrey)
        • Principal Investigator:
          • Juanita Lopez
  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists - Lake Nona
        • Principal Investigator:
          • Cesar Perez Batista, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Bruno Bockorny, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Kartik Sehgal
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • Edwin C Kingsley
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Afshin Dowlati
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Rachel E Sanborn
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Rachel E Sanborn
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center
        • Contact:
        • Principal Investigator:
          • Steven Powell
    • Texas
      • Houston, Texas, United States, 77030-4095
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Principal Investigator:
          • Sarina A Piha-Paul
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics
        • Contact:
        • Principal Investigator:
          • Amita Patnaik
    • Washington
      • Olympia, Washington, United States, 98506
        • Recruiting
        • Vista Oncology Inc PS
        • Contact:
        • Principal Investigator:
          • Joseph Z Ye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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-(L)1 inhibitor, if applicable and available.
    • Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab 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. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or [neo]adjuvant therapy is allowed).
    • Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.

  • 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 prior to first dose of study drug 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-(L)1, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose escalation
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
Experimental: Part B: Dose expansion
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: cisplatin
75 mg/m2 every 3 weeks, given by IV
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: cisplatin
75 mg/m2 every 3 weeks, given by IV
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Number of patients with laboratory abnormalities
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 3 years
The time from the start of any study treatment to the date of death due to any cause
Up to approximately 3 years
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause
Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the start of any study treatment to the first documentation of PD, or death due to any cause
Up to approximately 3 years
Area under the concentration-time curve (AUC)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Pharmacokinetic (PK) endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Concentration at the end of infusion (Ceoi)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Maximum observed concentration (Cmax)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Time to maximum observed concentration (Tmax)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trough concentration (Ctrough)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Apparent terminal elimination half-life (t1/2)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with antidrug antibodies (ADAs)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Jonathan Hayman, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNB6A-001
  • 2023-508469-34 (Other Identifier: Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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