RecruitingPhase 1NCT06952010
A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Sponsor
Exelixis
Enrollment
75 participants
Start Date
May 1, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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.
Exclusion Criteria5
- 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.
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Interventions
BIOLOGICALXB628
Intravenous infusion(s)
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06952010
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