This study is in progress, not accepting new patients

An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

a study on Solid Tumor Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lawrence Fong
Headshot of Lawrence Fong
Lawrence Fong

Description

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

Official Title

A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Keywords

Solid Tumors, Neoplasms, Atezolizumab, XmAb24306

Eligibility

For people ages 18 years and up

Key General Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >/= 12 weeks
  • Adequate hematologic and end-organ function
  • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative serum pregnancy test for women of childbearing potential
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Availability of representative tumor specimens

Key General Exclusion Criteria

  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Significant cardiovascular disease
  • Current treatment with medications that prolong the QT interval
  • Known clinically significant liver disease
  • Poorly controlled Type 2 diabetes mellitus
  • Symptomatic, untreated, or actively progressing CNS metastases
  • History of leptomeningeal disease
  • History of malignancy other than disease under study within 3 years prior to screening
  • Active or history of autoimmune disease or immune deficiency
  • Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
  • Positive for HIV infection
  • Prior allogeneic stem cell or solid organ transplantation

Locations

  • UCSF Helen Diller Family CCC
    San Francisco California 94158 United States
  • Stanford Health Centre - Palo Alto
    Palo Alto California 94304 United States

Lead Scientist at UCSF

  • Lawrence Fong
    Lawrence Fong, M.D. is the Efim Guzik Distinguished Professor in Cancer Biology in the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, where he leads the Cancer Immunotherapy Program. He also co-directs the Parker Institute of Cancer Immunotherapy at UCSF and co-leads the Cancer Immunity and Immunotherapy Program in the Cancer Center.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04250155
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated