Brief Title: A Study of SGN-B6A in Advanced Solid Tumors

PRIMARY OUTCOMES

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

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

Primary Outcome 2 - Measure: Number of patients with laboratory abnormalities

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

Primary Outcome 3 - Measure: Number of participants with dose-limiting toxicities (DLTs)

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

CONDITION

• 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

ELIGIBILITY

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)

- 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 D: Have not received frontline systemic therapy for locally advanced or metastatic disease (prior definitively intended or adjuvant therapy is allowed with the exception of PD-[L]1)
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 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.
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

- Part C Only: Prior therapy with a PD-1 inhibitor, anti-PD-L1, 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).

- Part D Only: Has NSCLC with an actionable genomic alteration

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Natalya Nazarenko, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Natalya Nazarenko, MD

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION