Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Jonathan W Riess (ucdavis)

Description

Summary

This study will test the safety of a drug called SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have four parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D, participants will be given SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Official Title

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Keywords

Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma, Ovarian Neoplasms, Melanoma, Triple Negative Breast Neoplasms, Gastric Cancer, Non-small cell lung cancer, NSCLC, Head and neck squamous cell carcinoma, HNSCC, Ovarian cancer, Triple Negative Breast Cancer, TNBC, Seattle Genetics, Carcinoma, Neoplasms, Squamous Cell Carcinoma, Stomach Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, SGN-PDL1V, SGN-PDL1V Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Parts A and B:
    • Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
    • Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
    • Participants must have PD-L1 expression based on historical testing
  • Part C:
    • Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
      • HNSCC

        - Participants with HNSCC must have histologically or cytologically-confirmed HNSCC

      • NSCLC

        - Participants must have histologically or cytologically-confirmed NSCLC

      • Esophageal SCC
      • Ovarian cancer
      • Melanoma
      • TNBC
      • Gastric cancer
    • Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing
  • Part D:
    • Participants must have histologically or cytologically-confirmed disease of the HNSCC
    • Participants must have PD-L1 expression based on historical testing
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline

You CAN'T join if...

  • History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
  • 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 associate with brain metastases for at least 7 days prior to first dose of study treatment
  • Lepto-meningeal disease
  • Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
  • Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
  • Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

    There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Locations

  • University of California Davis accepting new patients
    Sacramento California 95817 United States
  • South Texas Accelerated Research Therapeutics Mountain Region accepting new patients
    West Valley City Utah 84119 United States

Lead Scientist at University of California Health

  • Jonathan W Riess (ucdavis)
    Associate Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 106 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT05208762
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 322 study participants
Last Updated