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

INTRODUCTION

  • Org Study ID: SGNB6A-001
  • Secondary ID: N/A
  • NTC ID: NCT04389632
  • Sponsor: Seagen 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.

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with treatment-emergent 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 participants with Grade 3 or higher AEs

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 serious AEs

Primary Outcome 3 - Timeframe: 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 - Timeframe: 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 - Timeframe: 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 - Timeframe: 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 - Timeframe: Up to 21 days after the first dose

CONDITION

  • Carcinoma
  • Non-small Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • HER2 Negative Breast Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • 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)

- Cutaneous squamous cell cancer (cSCC)

- Exocrine pancreatic adenocarcinoma

- Bladder cancer

- Cervical cancer

- Gastric cancer

- High grade serous ovarian cancer (HGSOC)
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

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

Facility Status Contact