What this study is
This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
What's being tested
- XB628
Intervention · BIOLOGICAL
Intravenous infusion(s)
- Zanzalintinib
Intervention · DRUG
Oral tablet(s)
Study details
- Official title
- A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors
- Sponsor
- Exelixis
- Conditions
- Solid Tumor · Advanced Solid Tumor · Metastatic Solid Tumor · Immune Sensitive Tumor
- Enrolling
- 303 people
- Starts
- 2025-05-01
- Est. completion
- 2027-11-30
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
11 openExelixis Clinical Site #5
San Francisco, California, United States
RecruitingExelixis Clinical Site #4
New Haven, Connecticut, United States
RecruitingExelixis Clinical Site #8
Tampa, Florida, United States
RecruitingExelixis Clinical Site #10
Boston, Massachusetts, United States
RecruitingExelixis Clinical Site #11
Boston, Massachusetts, United States
RecruitingExelixis Clinical Site #6
St Louis, Missouri, United States
RecruitingExelixis Clinical Site #7
New York, New York, United States
RecruitingExelixis Clinical Site #1
Hickory, North Carolina, United States
RecruitingExelixis Clinical Site #3
Nashville, Tennessee, United States
RecruitingExelixis Clinical Site #9
Houston, Texas, United States
RecruitingExelixis Clinical Site #2
San Antonio, Texas, United States
Recruiting
Study team
Sponsor
Exelixis
Study ID XB628-101
Study director
Medical Director
Exelixis
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.