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BRIEF TITLE: SGN-B6A in Advanced Solid Tumors

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


  • Org Study ID: SGNB6A-001
  • Secondary ID:
  • NCT ID: NCT04389632
  • NCT Alias:
  • Sponsor: Seattle Genetics, Inc. - Industry
  • Source: Seattle Genetics, Inc.

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.

Overal Status Start Date Phase Study Type
Recruiting June 8, 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with treatment-emergent adverse events (AEs)

Primary Outcome 1 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 2 - Measure: Number of participants with Grade 3 or higher AEs

Primary Outcome 2 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 3 - Measure: Number of participants with serious AEs

Primary Outcome 3 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 4 - Measure: Number of participants with treatment-related AEs

Primary Outcome 4 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 5 - Measure: Number of patients with laboratory abnormalities

Primary Outcome 5 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 6 - Measure: Number of participants with DLTs

Primary Outcome 6 - Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years

Primary Outcome 7 - Measure: Number of participants with a DLT at each dose level

Primary Outcome 7 - Time Frame: Up to 21 days

Condition:

  • Non-small Cell Lung Cancer
  • Head and Neck Squamous Cell Cancer
  • Breast Cancer
  • Esophageal Cancer
  • Ovarian Cancer
  • Cutaneous Squamous Cell Cancer
  • Exocrine Pancreatic Adenocarcinoma
  • Bladder Cancer
  • Cervical Cancer
  • Gastric Cancer

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). 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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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Natalya Nazarenko, MD

Role: Study Director

Affiliation: Seattle Genetics, Inc.

Overall Contact

Name: Seattle Genetics Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

Locations

Facility Status Contact
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Recruiting Stephanie Stamatis
216-844-7087
Stephanie.Stamatis@UHhospitals.org
South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United States
Recruiting Lauryn Tuckett
210-593-5242
lauryn.tuckett@startsa.com