SGN-B6A for Esophageal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Esophageal Cancer+25 MoreSGN-B6A - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether a drug called SGN-B6A is safe for people with solid tumors, what its side effects are, and whether it works to treat cancer.

Eligible Conditions
  • Esophageal Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Non-small Cell Lung Cancer
  • Stomach Tumors
  • Non-Small Cell Lung Cancer
  • Ovarian Tumors
  • Pancreatic Cancer
  • HER2 Negative Breast Cancer
  • Bladder Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Cervical Cancer
  • Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 12 Secondary · Reporting Duration: Up to approximately 3 years

Year 3
Apparent terminal elimination half-life (t1/2)
Area under the concentration-time curve (AUC)
Concentration at the end of infusion (Ceoi)
Maximum observed concentration (Cmax)
Number of participants with DLTs
Number of participants with Grade 3 or higher AEs
Number of participants with adverse events (AEs)
Number of participants with antidrug antibodies
Number of participants with antidrug antibodies (ADAs)
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with serious AEs
Number of participants with treatment-emergent adverse events (AEs)
Number of participants with treatment-related AEs
Number of patients with laboratory abnormalities
Time to maximum observed concentration (Tmax)
Trough concentration (Ctrough)
Day 21
Number of participants with a DLT at each dose level
Year 3
Duration of objective response (DOR)
Objective response rate (ORR) per RECIST v1.1
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

SGN-B6A
1 of 1

Experimental Treatment

355 Total Participants · 1 Treatment Group

Primary Treatment: SGN-B6A · No Placebo Group · Phase 1

SGN-B6A
Drug
Experimental Group · 1 Intervention: SGN-B6A · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
185 Previous Clinical Trials
61,188 Total Patients Enrolled
Natalya Nazarenko, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
375 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically confirmed metastatic or unresectable solid malignancy.
You have an indication for a blood test.
You have non-small cell lung cancer (NSCLC).
You have HER2-negative advanced breast cancer.
You have a pancreatic adenocarcinoma.

Who else is applying?

What state do they live in?
Arkansas100.0%
How old are they?
65+100.0%
What site did they apply to?
MD Anderson Cancer Center / University of Texas100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%