Actively Recruiting
A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Led by Exelixis · Updated on 2026-05-14
75
Participants Needed
11
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating XB628, a new type of bispecific antibody natural killer (NK) cell engager designed to target NKG2A, an inhibitory receptor on NK cells, and PD-L1, in people with recurrent advanced or metastatic solid tumors. This phase 1, first-in-human trial aims to find the highest safe dose and the recommended dose for further study of XB628 as a single treatment. The study focuses on participants who have already received prior systemic anticancer therapy and have tumors not suitable for curative surgery or radiation. Participants will receive escalating doses of XB628 through intravenous infusions during the dose-escalation stage. The goal is to determine the maximum tolerated dose and recommended dosage(s) for expansion. The study is open-label, meaning both researchers and participants know the treatment being given. Participants will be closely monitored throughout the treatment period, which includes assessing their response to the drug and any side effects. During the study, participants will have regular evaluations including monitoring for dose-limiting toxicities and treatment-emergent adverse events over 21 days and up to 27 months. Blood samples will be collected to measure drug concentration and immune response. Researchers will also track how the drug is processed in the body and the overall tumor response. The total participation duration can be up to 27 months, during which safety and treatment effects will be carefully assessed.
CONDITIONS
Brief Title
A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Minimum life expectancy of 2 12 weeks.
- Histologically or cytologically confirmed recurrent advanced or metastatic solid tumor.
- Adequate organ and marrow function.
- Tumor not suitable for curative surgery or radiation.
- Received at least 1 prior systemic anticancer therapy for recurrent or metastatic disease.
- Alternative therapy was received, refused, intolerable, or no longer effective.
- Able to understand and comply with study requirements and provide signed informed consent.
You will not qualify if you...
- Primary brain tumors or known active brain metastases.
- Major surgery within 4 weeks before starting study treatment.
- Radiation therapy within 1 week before starting study treatment or ongoing complications from prior radiation.
- Prior therapy targeting natural killer (NK) cells, such as monalizumab.
- Positive serum pregnancy test within 7 days prior to study treatment in women of childbearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity.
Participants receive escalating dose levels of XB628 as a single agent through intravenous infusions.
Multiple visits for dosing and assessments during each cycle
Trial Site Locations
Total: 11 locations
1
Exelixis Clinical Site #5
San Francisco, California, United States, 94158
Actively Recruiting
2
Exelixis Clinical Site #4
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Exelixis Clinical Site #8
Tampa, Florida, United States, 33612
Actively Recruiting
4
Exelixis Clinical Site #10
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Exelixis Clinical Site #11
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Exelixis Clinical Site #6
St Louis, Missouri, United States, 63108
Actively Recruiting
7
Exelixis Clinical Site #7
New York, New York, United States, 10029
Actively Recruiting
8
Exelixis Clinical Site #1
Hickory, North Carolina, United States, 28602
Actively Recruiting
9
Exelixis Clinical Site #3
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Exelixis Clinical Site #9
Houston, Texas, United States, 77030
Actively Recruiting
11
Exelixis Clinical Site #2
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
Exelixis Clinical Trials
B
Backup or International
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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