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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    355
  • sponsor
    Seagen Inc.
Updated on 22 September 2022
cancer
measurable disease
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
pancreatic adenocarcinoma
esophageal cancer
HER2
gastric cancer
adenocarcinoma
solid tumour
ovarian cancer
erbb2
bladder cancer
esophagus cancer
bladder tumor
her2/neu-negative breast cancer
cancer, ovarian
cancer of the ovary
lung carcinoma

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.

Details
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
Treatment SGN-B6A
Clinical Study IdentifierNCT04389632
SponsorSeagen Inc.
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

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)
Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
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 16 onwards: pretreatment biopsy
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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