SGNB6A-001: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Indication :

NSCLC, HNSCC, ESCC, HGSOC, cSCC, cancer du sein HER2 négative avancé, Adénocarcinome oesophagien/adénocarci-nome gastro-oesophagien, cancer de la vessie, cancer degestif, cancer du col de l'utérus

Sponsor :

Seagen Inc.

Phase :


Ligne :


Traitement :


Site :


Contact(s) :
Solange Peters
Investigateur Principale

Département d'oncologie

Rue du Bugnon 46


Primary objective :

● To evaluate the safety and tolerability of SGN-B6A in subjects with advanced solid tumors
● To identify the maximum tolerated dose (MTD) of SGN-B6A in subjects with advanced solid tumors
● To identify a recommended dose and schedule for SGN-B6A

Inclusion criteria :

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)
  • EAC/GEJ adenocarcinoma
  • 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 16 onwards: pre-treatment biopsy
  • Biology expansion cohort: pre-treatment 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. Rue du Bugnon 46Routine antimicrobial prophylaxis is permitted