A Study of SGN-B6A in Advanced Solid Tumors Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on November 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified November 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: November 13, 2024
Last Verified: November 2024
History of Changes

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Tracking Information
First Submitted Date	May 12, 2020
First Posted Date	May 15, 2020
Last Update Posted Date	November 13, 2024
Study Start Date	June 8, 2020
Anticipated Primary Completion Date	November 30, 2026
Current Primary Outcome Measures (submitted: November 12, 2024)	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]
Change History	Complete list of historical versions of study NCT04389632 on ClinicalTrials.gov Archive Site
Current 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]
Current Other Outcome Measures	Not Provided

Descriptive Information
Brief Title	A Study of SGN-B6A in Advanced Solid Tumors
Official Title	A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: N/A Interventional Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
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
Intervention	Drug: sigvotatug vedotin Administered into the vein (IV; intravenously)
Study Groups/Cohorts	Experimental: Part A: Dose escalation sigvotatug vedotin monotherapy Intervention: Drug: sigvotatug vedotin Experimental: Part B: Dose expansion sigvotatug vedotin monotherapy Intervention: Drug: sigvotatug vedotin Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin) Intervention: Drug: sigvotatug vedotin Drug: pembrolizumab Drug: cisplatin Drug: carboplatin Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC sigvotatug vedotin + pembrolizumab +/- (carboplatin) Intervention: Drug: sigvotatug vedotin Drug: pembrolizumab Drug: carboplatin Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin) Intervention: Drug: sigvotatug vedotin Drug: pembrolizumab Drug: cisplatin Drug: carboplatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status	Recruiting
Anticipated Enrollment (submitted: November 12, 2024)	824
Anticipated Study Completion Date	February 28, 2028
Anticipated Primary Study Completion Date	November 30, 2026
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and Older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact: Seagen Trial Information Support, phone: 866-333-7436, email: clinicaltrials@seagen.com
Listed Location Countries	United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, France, France, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Switzerland, Taiwan, United Kingdom, United Kingdom

Administrative Information
NCT Number	NCT04389632
Other Study ID Numbers	SGNB6A-001
Has Data Monitoring Committee	No
U.S FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Seagen Inc., Seagen Inc.
Study Sponsor	Seagen Inc.
Collaborators	Not Provided
Investigators
PRS Account	Seagen Inc.
Verification Date	November 2024