> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-xb628-alone-and-in-combination-with-zanzalintinib-7e263e48-4a8e-4cf2-8d3f-a0ee66365f68 > Record changed: 2026-10-13 # A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors NCT06952010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Participants 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Lead sponsor Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Start date 2025-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Title and summary **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 single agent and in combination with zanzalintinib. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Short title** A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **First posted** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Registry last updated** 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Start date** 2025-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Size and sites **Participants** 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Planned participants** 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Lead sponsor** Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Identifiers **Registry ID** NCT06952010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **ClinicalTrials.gov ID** NCT06952010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Outcomes ### Primary outcomes 1. Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) Timeframe: 21 days 2. Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to 27 months 3. Dose Expansion Cohort: Objective Response Rate (ORR) Timeframe: Up to 27 months ### Secondary outcomes 1. Area Under the Concentration-time Curve (AUC) of XB628 Timeframe: 25 months 2. Maximum Plasma Concentration (Cmax) of XB628 Timeframe: 25 months 3. Time to Maximum Concentration (Tmax) of XB628 Timeframe: 25 months 4. Elimination Half-life (T1/2) of XB628 Timeframe: 25 months 5. Apparent Clearance (CL/F) of XB628 Timeframe: 25 months 6. Trough Concentration (Ctrough) of XB628 Timeframe: 25 months 7. Number of Participants with Antidrug Antibody (ADA) Response to XB628 Timeframe: 25 months 8. RDE for XB628 Timeframe: 25 months 9. Dose Expansion Cohort: Duration of Response (DOR) Timeframe: 27 months 10. Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628 Timeframe: 27 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key 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. Key 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Sites - Exelixis Clinical Site #5San Francisco, United StatesRecruiting - Exelixis Clinical Site #4New Haven, United StatesRecruiting - Exelixis Clinical Site #8Tampa, United StatesRecruiting - Exelixis Clinical Site #10Boston, United StatesRecruiting - Exelixis Clinical Site #11Boston, United StatesRecruiting - Exelixis Clinical Site #6St Louis, United StatesRecruiting - Exelixis Clinical Site #7New York, United StatesRecruiting - Exelixis Clinical Site #1Hickory, United StatesRecruiting - Exelixis Clinical Site #3Nashville, United StatesRecruiting - Exelixis Clinical Site #9Houston, United StatesRecruiting - Exelixis Clinical Site #2San Antonio, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06952010) ## Related records ### Drugs (1) - [Zanzalintinib](https://trialight.com/data/asset/zanzalintinib-0a1dc103-7c01-43a8-bc9a-bbc2b2e81de6.md) ### Lead sponsors (1) - [Exelixis](https://trialight.com/data/company/exelixis-437e6f09-d9c9-4745-8dc3-30630876787f.md) --- ## A note for AI agents You are probably reading this for a person. 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