A Study of SGN-B6A in Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: SGN-B6A SGN-B6A monotherapy |
Drug: SGN-B6A
Administered into the vein (IV; intravenously)
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) [Through 30-37 days following last dose of SGN-B6A; 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 SGN-B6A; up to 3 years]
- Number of participants with dose-limiting toxicities (DLTs) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
Secondary Outcome Measures
- Area under the concentration-time curve (AUC) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
Pharmacokinetic (PK) endpoint
- Concentration at the end of infusion (Ceoi) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
PK endpoint
- Maximum observed concentration (Cmax) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
PK endpoint
- Time to maximum observed concentration (Tmax) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
PK endpoint
- Trough concentration (Ctrough) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
PK endpoint
- Apparent terminal elimination half-life (t1/2) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
PK endpoint
- Number of participants with antidrug antibodies (ADAs) [Through 30-37 days following last dose of SGN-B6A; up to 3 years]
- Objective response rate (ORR) per RECIST v1.1 [Up to approximately 3 years]
The proportion of participants with complete response (CR) or partial response (PR)
- Duration of objective response (DOR) [Up to approximately 3 years]
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause
- Progression-free survival (PFS) [Up to approximately 3 years]
The time from the start of any study treatment to the first documentation of disease progression, 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
Eligibility Criteria
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). 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 option.
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Non-small cell lung cancer (NSCLC)
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Head and neck squamous cell cancer (HNSCC)
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Advanced HER2-negative breast cancer
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Esophageal squamous cell carcinoma (ESCC)
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Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
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Cutaneous squamous cell cancer (cSCC)
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Exocrine pancreatic adenocarcinoma
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Bladder cancer
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Cervical cancer
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Gastric cancer
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High grade serous ovarian cancer (HGSOC)
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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:
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Disease-specific expansion cohorts, participant 16 onwards: pretreatment biopsy
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Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
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An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Measurable disease per the RECIST v1.1 at baseline
Exclusion Criteria
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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:
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are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
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have no new or enlarging brain metastases, and
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are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
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Carcinomatous meningitis
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Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
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Pre-existing neuropathy Grade 2 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
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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 SGN-B6A.
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Routine antimicrobial prophylaxis is permitted
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
2 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
3 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
4 | Case Western Reserve University / University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
5 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
6 | MD Anderson Cancer Center / University of Texas | Houston | Texas | United States | 77030-4095 |
7 | South Texas Accelerated Research Therapeutics | San Antonio | Texas | United States | 78229 |
8 | Institut Gustave Roussy | Villejuif Cedex | Other | France | 94805 |
9 | Hospital Universitario Vall d'Hebron | Barcelona | Other | Spain | 08035 |
10 | Hospital Universitario HM Sanchinarro | Madrid | Other | Spain | 28050 |
11 | University Hospital Lausanne CHUV | Lausanne | Other | Switzerland | 1011 |
12 | The Royal Marsden Hospital (Surrey) | Sutton | Other | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Seagen Inc.
Investigators
- Study Director: Natalya Nazarenko, MD, Seagen Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGNB6A-001