Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Kelly Fitzgerald (ucsf)
Headshot of Kelly Fitzgerald
Kelly Fitzgerald

Description

Summary

This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.

Official Title

A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors

Keywords

Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor, XB628, PD-L1, Zanzalintinib, Neoplasm Metastasis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Minimum life expectancy of ≥ 12 weeks.
  • Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
  • Adequate organ and marrow function.
  • Not amenable to curative treatment with surgery or radiation.
  • Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
  • Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
  • Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.

You CAN'T join if...

  • Primary brain tumors or known active brain metastases.
  • Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
  • Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
  • Received prior therapy targeting NK cells (eg, monalizumab).
  • A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • Exelixis Clinical Site #5 accepting new patients
    San Francisco California 94158 United States
  • Exelixis Clinical Site #2 accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at University of California Health

  • Kelly Fitzgerald (ucsf)
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Exelixis
ID
NCT06952010
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 303 study participants
Last Updated