Trial record 1 of 1 for:
SGNB6A-001
A Study of SGN-B6A in Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04389632 |
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Recruitment Status :
Recruiting
First Posted : May 15, 2020
Last Update Posted : April 16, 2024
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Sponsor:
Seagen Inc.
Information provided by (Responsible Party):
Seagen Inc.
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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.
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In Parts C and D, participants will receive sigvotatug vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 824 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors |
| Actual Study Start Date : | June 8, 2020 |
| Estimated Primary Completion Date : | November 30, 2026 |
| Estimated Study Completion Date : | October 31, 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part A: Dose escalation
sigvotatug vedotin monotherapy
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Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Name: SGN-B6A |
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Experimental: Part B: Dose expansion
sigvotatug vedotin monotherapy
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Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Name: SGN-B6A |
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Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
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Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Name: SGN-B6A Drug: pembrolizumab 200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Name: 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 |
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Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
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Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Name: SGN-B6A Drug: pembrolizumab 200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Name: Keytruda Drug: carboplatin AUC 5 mg/mL per min every 3 weeks, given by IV |
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Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
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Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Name: SGN-B6A Drug: pembrolizumab 200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Name: 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 |
Primary Outcome Measures :
- 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.
- Number of patients with laboratory abnormalities [ Time Frame: 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 ]
Secondary Outcome Measures :
- 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.
- 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
- 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
- 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
- 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
- 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
- Maximum observed concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]PK endpoint
- Time to maximum observed concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]PK endpoint
- Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]PK endpoint
- 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
- Number of participants with antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Disease indication
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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.
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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.
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389632
Contacts
| Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
Locations
Show 21 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
| Study Director: | Jonathan Hayman, MD | Seagen Inc. |
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT04389632 |
| Other Study ID Numbers: |
SGNB6A-001 2023-508469-34 ( Other Identifier: Registry Identifier: CTIS (EU) ) |
| First Posted: | May 15, 2020 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Seagen Inc.:
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NSCLC HNSCC cSCC ESCC EAC GEJ HGSOC Advanced HER2-Negative Breast Cancer |
High Grade Serous Ovarian Cancer Non-Small Cell Lung Cancer Head and Neck Squamous Cell Cancer Esophageal Cancer Bladder Cancer Cervical Cancer Gastric Cancer Seattle Genetics |
Additional relevant MeSH terms:
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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 |