A Study of SGN-B6A in Advanced Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    235
  • sponsor
    Seattle Genetics, Inc.
Updated on 19 February 2024
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 18-100 years
Treatment SGN-B6A
Clinical Study IdentifierNCT04389632
SponsorSeattle Genetics, Inc.
Last Modified on19 February 2024

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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