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

ClinicalTrials.gov processed this data on July 8, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified July 2024 by Seagen Inc.

Sponsor

Seagen Inc.

Information Provided by (Responsible Party)

Seagen Inc.

Clinicaltrials.gov Identifier

NCT04389632
Other Study ID Numbers: SGNB6A-001
First Submitted: May 12, 2020
First Posted: May 15, 2020
Last Update Posted: July 9, 2024
Last Verified: July 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • 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
  • Drug: sigvotatug vedotin
  • Drug: pembrolizumab
  • Drug: cisplatin
  • Drug: carboplatin

Study Design

Study TypeInterventional
Anticipated Enrollment824 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Study Start DateJune 8, 2020
Anticipated Primary Completion DateNovember 30, 2026
Anticipated Study Completion DateOctober 31, 2028

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Part A: Dose escalation
    • sigvotatug vedotin monotherapy
  • Drug: sigvotatug vedotin
    • Administered into the vein (IV; intravenously)
  • Part B: Dose expansion
    • sigvotatug vedotin monotherapy
  • Drug: sigvotatug vedotin
    • Administered into the vein (IV; intravenously)
  • Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
    • sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
  • Drug: sigvotatug vedotin
    • Administered into the vein (IV; intravenously)
  • Drug: pembrolizumab
    • Drug: cisplatin
      • Drug: carboplatin
        • Part D: sigvotatug vedotin combination therapy in 1L NSCLC
          • sigvotatug vedotin + pembrolizumab +/- (carboplatin)
        • Drug: sigvotatug vedotin
          • Administered into the vein (IV; intravenously)
        • Drug: pembrolizumab
          • Drug: carboplatin
            • Part D: sigvotatug vedotin combination therapy in 1L HNSCC
              • sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
            • Drug: sigvotatug vedotin
              • Administered into the vein (IV; intravenously)
            • Drug: pembrolizumab
              • Drug: cisplatin
                • Drug: carboplatin

                  Outcome Measures

                  Primary Outcome Measures

                  1. Number of participants with adverse events (AEs) [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.
                  2. Number of patients with laboratory abnormalities [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                  3. Number of participants with dose-limiting toxicities (DLTs) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]

                  Secondary Outcome Measures

                  1. Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment [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.
                  2. Duration of objective response (DOR) per RECIST v1.1 by investigator assessment [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
                  3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment [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
                  4. Overall survival (OS) [Up to approximately 3 years]
                    The time from the start of any study treatment to the date of death due to any cause
                  5. Area under the concentration-time curve (AUC) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    Pharmacokinetic (PK) endpoint
                  6. Concentration at the end of infusion (Ceoi) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    PK endpoint
                  7. Maximum observed concentration (Cmax) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    PK endpoint
                  8. Time to maximum observed concentration (Tmax) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    PK endpoint
                  9. Trough concentration (Ctrough) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    PK endpoint
                  10. Apparent terminal elimination half-life (t1/2) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
                    PK endpoint
                  11. Number of participants with antidrug antibodies (ADAs) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]

                  Eligibility Criteria

                  Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
                  Sexes Eligible for Study All
                  Accepts Healthy Volunteers No
                  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
                  • istory 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

                  Contacts and Locations

                  Sponsors and Collaborators Seagen Inc.
                  Locations
                  • Florida Cancer Specialists - Lake Nona | Orlando, Florida, United States, 32827
                  • Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States, 02215
                  • Dana Farber Cancer Institute | Boston, Massachusetts, United States, 02215
                  • Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, United States, 89169
                  • University Hospitals Cleveland Medical Center | Cleveland, Ohio, United States, 44106
                  • Providence Portland Medical Center | Portland, Oregon, United States, 97213
                  • Providence Portland Medical Center | Portland, Oregon, United States, 97225
                  • Sanford Cancer Center | Sioux Falls, South Dakota, United States, 57104
                  • MD Anderson Cancer Center / University of Texas | Houston, Texas, United States, 77030-4095
                  • South Texas Accelerated Research Therapeutics | San Antonio, Texas, United States, 78229
                  • Vista Oncology Inc PS | Olympia, Washington, United States, 98506
                  • Northwest Medical Specialties, PPLC | Tacoma, Washington, United States, 98405
                  • Institut Gustave Roussy | Villejuif Cedex, Other, France, 94805
                  • Hospital HM Nou Delfos | Barcelona, Other, Spain, 08023
                  • Hospital Universitari Vall d'Hebron | Barcelona, Other, Spain, 08035
                  • Elche General University Hospital | Elche, Other, Spain, 03203
                  • Hospital Universitario De Jerez | Jerez de la Frontera, Other, Spain, 11407
                  • Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos | Madrid, Other, Spain, 28034
                  • START Madrid-CIOCC_Hospital HM Sanchinarro | Madrid, Other, Spain, 28050
                  • Hospital Universitario Marques de Valdecilla | Santander, Other, Spain, 39008
                  • University Hospital Lausanne CHUV | Lausanne, Other, Switzerland, 1011
                  • Sarah Cannon Research Institute UK | London, Other, United Kingdom, W1G 6AD
                  • The Royal Marsden Hospital (Surrey) | Sutton, Other, United Kingdom, SM2 5PT
                  Investigators

                    More Information

                    Additional Relevant MeSH Terms

                    • Carcinoma
                    • Neoplasms
                    • Carcinoma, Squamous Cell
                    • Adenocarcinoma
                    • Breast Neoplasms
                    • Esophageal Squamous Cell Carcinoma
                    • Carcinoma, Non-Small-Cell Lung
                    • Neoplasms, Squamous Cell
                    • Ovarian Neoplasms
                    • Stomach Neoplasms
                    • Squamous Cell Carcinoma of Head and Neck
                    • Urinary Bladder Neoplasms
                    • Uterine Cervical Neoplasms
                    • Neoplasms, Glandular and Epithelial
                    • Neoplasms by Histologic Type
                    • Neoplasms by Site
                    • Breast Diseases
                    • Skin Diseases
                    • Esophageal Neoplasms
                    • Gastrointestinal Neoplasms
                    • Digestive System Neoplasms
                    • Head and Neck Neoplasms
                    • Digestive System Diseases
                    • Esophageal Diseases
                    • Gastrointestinal Diseases
                    • Carcinoma, Bronchogenic
                    • Bronchial Neoplasms
                    • Lung Neoplasms
                    • Respiratory Tract Neoplasms
                    • Thoracic Neoplasms
                    • Lung Diseases
                    • Respiratory Tract Diseases
                    • Endocrine Gland Neoplasms
                    • Ovarian Diseases
                    • Adnexal Diseases
                    • Genital Diseases, Female
                    • Female Urogenital Diseases
                    • Female Urogenital Diseases and Pregnancy Complications
                    • Urogenital Diseases
                    • Genital Neoplasms, Female
                    • Urogenital Neoplasms
                    • Genital Diseases
                    • Endocrine System Diseases
                    • Gonadal Disorders
                    • Stomach Diseases
                    • Urologic Neoplasms
                    • Urinary Bladder Diseases
                    • Urologic Diseases
                    • Male Urogenital Diseases
                    • Uterine Neoplasms
                    • Uterine Cervical Diseases
                    • Uterine Diseases