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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06952010
- Acronym / sponsor ID
- XB628-101
- Keywords
- XB628, Solid tumor, Advanced solid tumor, Metastatic solid tumor, Immune sensitive tumor, PD-L1, Zanzalintinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Biological: XB628, Drug: ZanzalintinibParticipants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib. |
| Dose Expansion | Experimental | Biological: XB628, Drug: ZanzalintinibParticipants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XB628Intravenous infusion(s) | Biological | Dose Escalation Phase, Dose Expansion |
| ZanzalintinibAlso: XL092Oral tablet(s) | Drug | Dose Escalation Phase, Dose Expansion |
Primary outcome
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 21 days
Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 27 months
Dose Expansion Cohort: Objective Response Rate (ORR)
Time frame: Up to 27 months
10 secondary outcomes
Area Under the Concentration-time Curve (AUC) of XB628
Time frame: 25 months
Maximum Plasma Concentration (Cmax) of XB628
Time frame: 25 months
Time to Maximum Concentration (Tmax) of XB628
Time frame: 25 months
Elimination Half-life (T1/2) of XB628
Time frame: 25 months
Apparent Clearance (CL/F) of XB628
Time frame: 25 months
Trough Concentration (Ctrough) of XB628
Time frame: 25 months
Number of Participants with Antidrug Antibody (ADA) Response to XB628
Time frame: 25 months
RDE for XB628
Time frame: 25 months
Dose Expansion Cohort: Duration of Response (DOR)
Time frame: 27 months
Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628
Time frame: 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Backup or International contact
Medical Director study director
Exelixis
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Exelixis Clinical Trials (1-888-EXELIXIS (888-393-5494), druginfo@exelixis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.