Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

Summary

This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.

Official Title

A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Keywords

Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma, NSCLC, Colorectal Cancer, CRC, Pancreatic Cancer, Neoplasms, Melanoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
  • Participants must have one of the following tumor types:
  • A pre-treatment biopsy or submission of archival tissue is required
  • For participants with cutaneous melanoma
    • Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
    • Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.
  • 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 before the 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.
  • Active central nervous system metastases or leptomeningeal disease. 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,
    • they 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 the first dose of study drug.
  • Prior therapies cannot include any drugs targeting CD228 or 4-1BB
  • Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
  • Melanoma subtypes including acral, uveal, and mucosal are excluded

Locations

  • UCLA Hematology/Oncology - Administrative Office accepting new patients
    Los Angeles California 90024 United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • University of California Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • UCSF Medical Center, Investigational Pharmacy accepting new patients
    San Francisco California 94158 United States
  • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies accepting new patients
    San Francisco California 94158 United States
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only) accepting new patients
    Santa Monica California 90404 United States
  • The Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
ID
NCT05571839
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 275 study participants
Last Updated