A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Exelixis
Summary
This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).
Description
This study consists of a Dose-Escalation Stage. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB628 as a single agent.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 r…
Interventions
- BiologicalXB628
Intravenous infusion(s)
Locations (10)
- Exelixis Site #5San Francisco, California
- Exelixis Site #4New Haven, Connecticut
- Exelixis Clinical Site #8Tampa, Florida
- Exelixis Clinical Site #10Boston, Massachusetts
- Exelixis Site #6St Louis, Missouri
- Exelixis Site #7New York, New York