> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-xb010-in-subjects-with-solid-tumors-7b32e6ad-ac40-468e-b022-fb44e7b4b7f5 > Record changed: 2026-10-13 # Study of XB010 in Subjects With Solid Tumors NCT06545331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Participants 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Lead sponsor Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Start date 2024-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Title and summary **Summary** This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Short title** Study of XB010 in Subjects With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Official title** A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Dates **Completion date** 2027-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **First posted** 2024-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Registry last updated** 2026-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Primary completion date** 2026-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Start date** 2024-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Size and sites **Participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Planned participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Lead sponsor** Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Identifiers **Registry ID** NCT06545331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **ClinicalTrials.gov ID** NCT06545331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Outcomes ### Primary outcomes 1. Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion \[RDE(s)\] for XB010 Timeframe: 18 months To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy. 2. Dose-Escalation Stage: Safety of XB010 Timeframe: 18 months To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs) 3. Dose-Escalation Stage: Duration of exposure of XB010 \[Tolerability\] Timeframe: 18 months To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component 4. Dose-Escalation Stage: Dose intensity of XB010 \[Tolerability\] Timeframe: 18 months To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component 5. Cohort-Expansion Stage: Preliminary antitumor activity of XB010 Timeframe: 24 months Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 ### Secondary outcomes 1. Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010 Timeframe: 18 Months To evaluate the maximum plasma concentration of XB010 alone and in combination. 2. Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 Timeframe: 18 Months To evaluate the time to maximum plasma concentration of XB010 alone and in combination. 3. Dose-Escalation Stage: Clearance of XB010 Timeframe: 18 Months To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period 4. Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 Timeframe: 18 Months To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination 5. Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010 Timeframe: 18 Months To evaluate the minimum plasma concentration of XB010 alone and in combination 6. Dose-Escalation Stage: Immunogenicity of XB010 Timeframe: 18 Months To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis 7. Cohort-Expansion Stage: Duration of exposure of XB010 \[Tolerability\] Timeframe: 24 Months To evaluate the tolerability of XB010 through the evaluation of the duration of exposure 8. Cohort-Expansion Stage: Dose intensity of XB010 \[Tolerability\] Timeframe: 24 Months To evaluate the tolerability of XB010 through the evaluation of the dose intensity 9. Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010 Timeframe: 24 Months To evaluate the maximum plasma concentration of XB010 10. Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 Timeframe: 24 Months To evaluate the time to maximum plasma concentration of XB010 11. Cohort-Expansion Stage: Clearance of XB010 Timeframe: 24 Months To evaluate the volume of plasma cleared of XB010 for a specified time period 12. Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 Timeframe: 24 Months To measure the Area Under the Plasma Concentration Curve of XB010 13. Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010 Timeframe: 24 Months To evaluate the minimum plasma concentration of XB010 14. Cohort-Expansion Stage: Immunogenicity of XB010 Timeframe: 24 Months To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No - Age 18 years or older on the day of consent. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. - Adequate organ and marrow function. - Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. - The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer). - Capable of understanding and complying with the protocol requirements and must have signed the informed consent document. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Sites - City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesRecruiting - UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting - Georgetown University Medical CenterWashington D.C., United StatesRecruiting - Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesRecruiting - Winship Cancer InstituteAtlanta, United StatesRecruiting - University of Chicago Medical CenterChicago, United StatesRecruiting - Siteman Cancer CenterSt Louis, United StatesRecruiting - Montefiore Medical Center - Montefiore Medical ParkThe Bronx, United StatesRecruiting - Carolina BioOncology InstituteHuntersville, United StatesRecruiting - Stephenson Cancer CenterOklahoma City, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - NEXT AustinAustin, United StatesRecruiting - Baylor University Medical CenterDallas, United StatesRecruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Inova Schar CancerFairfax, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - University Hospitals of Leicester NHS TrustLeicester, United KingdomRecruiting - Sarah Cannon Research Institute LondonLondon, United KingdomRecruiting - University College London Hospitals NHS Foundation TrustLondon, United KingdomRecruiting - The Christie NHS Foundation TrustManchester, United KingdomRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## References ### Other registry identifiers - 1012465 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545331) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Exelixis](https://trialight.com/data/company/exelixis-437e6f09-d9c9-4745-8dc3-30630876787f.md) ### Conditions (4) - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) - [Hormone receptor-positive breast cancer](https://trialight.com/data/condition/hormone-receptor-positive-breast-cancer-1615b277-fa91-513c-addf-371a0c1fe840.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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