Status:
RECRUITING
A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Lead Sponsor:
Exelixis
Conditions:
Solid Tumor
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 inhibi...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 requirements and provide signed informed consent according to the protocol and local requirements.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06952010
Start Date
May 1 2025
End Date
November 1 2027
Last Update
December 26 2025
Active Locations (10)
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1
Exelixis Site #5
San Francisco, California, United States, 94158
2
Exelixis Site #4
New Haven, Connecticut, United States, 06520
3
Exelixis Clinical Site #8
Tampa, Florida, United States, 33612
4
Exelixis Clinical Site #10
Boston, Massachusetts, United States, 02114