A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
ClinicalTrials.gov processed this data on October 28, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified October 2024 by Seagen Inc.
Sponsor
Seagen Inc.Information Provided by (Responsible Party)
Seagen Inc.Clinicaltrials.gov Identifier
NCT04389632Other Study ID Numbers: SGNB6A-001
First Submitted: May 12, 2020
First Posted: May 15, 2020
Last Update Posted: October 29, 2024
Last Verified: October 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 824 participants |
Design Allocation | N/A |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors |
Study Start Date | June 8, 2020 |
Anticipated Primary Completion Date | November 30, 2026 |
Anticipated Study Completion Date | February 28, 2028 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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.
- Number of patients with laboratory abnormalities [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years]
- 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
- 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.
- 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
- 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
- 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
- Area under the concentration-time curve (AUC) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] Pharmacokinetic (PK) endpoint
- Concentration at the end of infusion (Ceoi) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] PK endpoint
- Maximum observed concentration (Cmax) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] PK endpoint
- Time to maximum observed concentration (Tmax) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] PK endpoint
- Trough concentration (Ctrough) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] PK endpoint
- Apparent terminal elimination half-life (t1/2) [Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years] PK endpoint
- 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) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Seagen Inc. |
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Locations |
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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
- Uterine Cervical Neoplasms
- Urinary Bladder 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
- Uterine Neoplasms
- Uterine Cervical Diseases
- Uterine Diseases
- Urologic Neoplasms
- Urinary Bladder Diseases
- Urologic Diseases
- Male Urogenital Diseases