Solid TumorPhase 1NCT06952010
A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
A Phase 1 study testing XB628 and Zanzalintinib in people with Solid Tumor and Advanced Solid Tumor, run by Exelixis at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- XB628 and Zanzalintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 May 2025to 30 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Backup or International contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Exelixis Clinical Site #10
Boston, Massachusetts, 02114
- Recruiting
Exelixis Clinical Site #11
Boston, Massachusetts, 02114
- Recruiting
Exelixis Clinical Site #1
Hickory, North Carolina, 28602
- Recruiting
Exelixis Clinical Site #9
Houston, Texas, 77030
- Recruiting
Exelixis Clinical Site #3
Nashville, Tennessee, 37203
- Recruiting
Exelixis Clinical Site #4
New Haven, Connecticut, 06520
- Recruiting
Exelixis Clinical Site #7
New York, New York, 10029
- Recruiting
Exelixis Clinical Site #2
San Antonio, Texas, 78229
- Recruiting
Exelixis Clinical Site #5
San Francisco, California, 94158
- Recruiting
Exelixis Clinical Site #6
St Louis, Missouri, 63108
- Recruiting
Exelixis Clinical Site #8
Tampa, Florida, 33612
About this study
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
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.
- Being tested
- XB628, Zanzalintinib
- Keywords
- XB628, Solid tumor, Advanced solid tumor, Metastatic solid tumor, Immune sensitive tumor, PD-L1, Zanzalintinib
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XB628Biological
Intravenous infusion(s)
ZanzalintinibDrug
Also called XL092
Oral tablet(s)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | Participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib. Receives: Biological: XB628; Drug: Zanzalintinib |
| Dose Expansion | Experimental | Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib. Receives: Biological: XB628; Drug: Zanzalintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: 21 days
Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 27 months
Dose Expansion Cohort: Objective Response Rate (ORR)
Measured: Up to 27 months
Secondary outcomes (10)
Area Under the Concentration-time Curve (AUC) of XB628
Measured: 25 months
Maximum Plasma Concentration (Cmax) of XB628
Measured: 25 months
Time to Maximum Concentration (Tmax) of XB628
Measured: 25 months
Elimination Half-life (T1/2) of XB628
Measured: 25 months
Apparent Clearance (CL/F) of XB628
Measured: 25 months
Trough Concentration (Ctrough) of XB628
Measured: 25 months
Number of Participants with Antidrug Antibody (ADA) Response to XB628
Measured: 25 months
RDE for XB628
Measured: 25 months
Dose Expansion Cohort: Duration of Response (DOR)
Measured: 27 months
Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952010
- Sponsor's protocol ID
- XB628-101
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No