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A Study of SGN-B6A in Advanced Solid Tumors

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Seagen

Status and phase

Enrolling
Phase 1

Conditions

Uterine Cervical Neoplasms
Ovarian Neoplasms
Cutaneous Squamous Cell Cancer
Urinary Bladder Neoplasms
Exocrine Pancreatic Adenocarcinoma
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
Stomach Neoplasms

Treatments

Drug: carboplatin
Drug: pembrolizumab
Drug: cisplatin
Drug: sigvotatug vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04389632
SGNB6A-001
2023-508469-34 (Other Identifier)

Details and patient eligibility

About

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

  • Part A of the study will find out how much sigvotatug vedotin should be given to participants.

  • Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.

  • Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.

  • Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.

  • In Parts C and D, participants will receive sigvotatug vedotin with either:

    • Pembrolizumab or,
    • Pembrolizumab and carboplatin, or
    • Pembrolizumab and cisplatin.

Enrollment

824 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

824 participants in 5 patient groups

Part A: Dose escalation
Experimental group
Description:
sigvotatug vedotin monotherapy
Treatment:
Drug: sigvotatug vedotin
Part B: Dose expansion
Experimental group
Description:
sigvotatug vedotin monotherapy
Treatment:
Drug: sigvotatug vedotin
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
Experimental group
Description:
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Treatment:
Drug: sigvotatug vedotin
Drug: cisplatin
Drug: pembrolizumab
Drug: carboplatin
Part D: sigvotatug vedotin combination therapy in 1L NSCLC
Experimental group
Description:
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Treatment:
Drug: sigvotatug vedotin
Drug: pembrolizumab
Drug: carboplatin
Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Experimental group
Description:
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Treatment:
Drug: sigvotatug vedotin
Drug: cisplatin
Drug: pembrolizumab
Drug: carboplatin

Trial contacts and locations

43

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Central trial contact

Seagen Trial Information Support

Data sourced from clinicaltrials.gov

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