> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-in-human-study-of-cx-801-in-advanced-solid-tumors-fe45403e-f4c3-498f-981b-8cff385fb668 > Record changed: 2026-11-04 # First In Human Study of CX-801 in Advanced Solid Tumors NCT06462794 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Participants 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Lead sponsor CytomX Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Start date 2024-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Title and summary **Summary** The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Short title** First In Human Study of CX-801 in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Official title** An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Dates **Completion date** 2029-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **First posted** 2024-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Primary completion date** 2028-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Start date** 2024-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Size and sites **Participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Planned participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Lead sponsor** CytomX Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Identifiers **Registry ID** NCT06462794 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **ClinicalTrials.gov ID** NCT06462794 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Outcomes ### Primary outcomes 1. Safety and tolerability of CX-801 as monotherapy and combination therapy Timeframe: 44 months The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level 2. Determine the recommended Phase 2 dose (RP2D) Timeframe: 44 months The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level ### Secondary outcomes 1. Objective response rate (ORR) Timeframe: 60 months ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment. 2. Duration of response (DOR) Timeframe: 60 months DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first. 3. Progression-free survival (PFS) Timeframe: 60 months PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. 4. Disease control rate (DCR) Timeframe: 60 months DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment. 5. Duration of disease control (DODC) Timeframe: 60 months DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first. 6. Overall survival (OS) Timeframe: 60 months OS defined as the time from the first dose of study intervention to death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Measurable disease per RECIST v1.1 - Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue - Adequate organ function - Additional inclusion criteria may apply ### Exclusion criteria - Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated - Known active central nervous system (CNS) involvement by malignancy - Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event - Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment - Investigational drug or device within 4 weeks prior to first dose of study treatment - Radiation within 2 weeks prior to first dose of study treatment - Serious concurrent illness - Pregnant or breast feeding - Additional exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Sites - The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, United StatesRecruiting - The Melanoma and Skin Cancer InstituteEnglewood, United StatesRecruiting - University of Pittsburgh Hillman Cancer CenterPittsburgh, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - START Dallas Fort Worth, LLCFort Worth, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## References ### Other registry identifiers - KEYNOTE-F95 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06462794) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [CytomX Therapeutics](https://trialight.com/data/company/cytomx-therapeutics-60926d97-ee88-4ffa-b307-aa0b48974f91.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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