A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

Description

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).

Conditions

Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Hickory

Exelixis Clinical Site #1, Hickory, North Carolina, United States, 28602

San Antonio

Exelixis Clinical Site #2, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 requirements and provide signed informed consent according to the protocol and local requirements.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exelixis,

Study Record Dates

2027-11