A Study of SGN-B6A in Advanced Solid Tumors

STATUS

Recruiting
participants needed

235
sponsor

Seattle Genetics, Inc.

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Updated on 19 February 2024

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cancer

breast cancer

measurable disease

bladder cancer

solid tumour

squamous cell carcinoma of head and neck

squamous cell carcinoma

lung cancer

ovarian cancer

cancer of the ovary

adenocarcinoma

gastric cancer

esophageal cancer

pancreatic adenocarcinoma

squamous cell carcinoma of the head and neck

cancer, ovarian

non-small cell lung cancer

cervical cancer

small cell lung cancer

ovarian ca

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.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Cervical Cancer, urinary tract neoplasm, Ovarian disorder, Uterine Cancer, Uterine Cancer, bladder cancer, bladder cancer, bladder disorder, Breast Cancer, Breast Cancer, Ovarian Cancer, Ovarian Cancer, Esophageal Diseases, Esophageal Cancer, Esophageal Cancer, Gastropathy, stomach discomfort, Gastric Cancer, Gastric Cancer, stomach cancer, head and neck cancer, head and neck cancer, stomach cancer, stomach discomfort, Head and Neck Squamous Cell Cancer, Cutaneous Squamous Cell Cancer, Exocrine Pancreatic Adenocarcinoma
Age	18years - 100years
Treatment	SGN-B6A
Clinical Study Identifier	NCT04389632
Sponsor	Seattle Genetics, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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). 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
	Non-small cell lung cancer (NSCLC)
	Head and neck squamous cell cancer (HNSCC)
	Breast cancer
	Esophageal cancer
	Cutaneous squamous cell cancer (SCC)
	Exocrine pancreatic adenocarcinoma
	Bladder cancer
	Cervical cancer
	Gastric cancer
	Ovarian cancer
	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, participant 13 onwards: pre-treatment biopsy
	Biology expansion cohort: pre-treatment biopsy and additional on-treatment biopsy during Cycle 1
	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
	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 2 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
	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
	Routine antimicrobial prophylaxis is permitted
	Positive for hepatitis B by surface antigen expression or active hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virolgic response of 12 weeks
	Known to be positive for human immunodeficiency virus (HIV)
	Documented history of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of SGN-B6A
	Congestive heart failure (Class III or IV) by New York Heart Association criteria
	Grade 3 or higher pulmonary disease unrelated to underlying malignancy
	Participant is expected to receive other anti-neoplastic or investigational agents prior to the end of treatment visit
	During dose escalation only, use of strong CYP3A inhibitors within 14 days of study drug dosing
	Chemotherapy, immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
	Focal radiotherapy or surgery that is not completed 2 weeks prior to the first dose of SGN-B6A
	Known hypersensitivity to any excipient contained in the drug formulation of SGN-B6A
	Estimated life expectancy of <12 weeks

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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A Study of SGN-B6A in Advanced Solid Tumors