A Study of SGN-B6A in Advanced Solid Tumors

Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · May 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called sigvotatug vedotin (SGN-B6A) to see how safe it is and if it can help treat various advanced solid tumors, such as lung cancer, breast cancer, and others. The trial will look at sigvotatug vedotin on its own, as well as in combination with another drug called pembrolizumab, and sometimes with chemotherapy. The study is divided into four parts: the first part will determine the right amount of the drug to give, while the next parts will test its safety and effectiveness when used alone or with other treatments.

To participate in this trial, individuals must have specific types of cancer that cannot be treated with standard therapies. They should also be in generally good health, with a performance status of 0 or 1, meaning they can carry out normal activities or are only slightly limited in their daily tasks. Participants will receive regular check-ups and may have to undergo biopsies to monitor their condition. This trial is currently accepting participants aged 65 and older, and it’s important to note that those with certain medical conditions or recent cancer treatments may not be eligible. If you or a loved one is considering participation, it could be an opportunity to access new treatment options and contribute to important cancer research.

Gender

ALL

Eligibility criteria

• 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).
• • 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 A only: 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 options.
• • Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available.
• • Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed).
• • Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.
• * 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 prior to first dose of study drug 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 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts
• • 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 sigvotatug vedotin.
• • Routine antimicrobial prophylaxis is permitted
• • Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
• • Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, 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).
• • History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening
• • Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted