> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-in-human-study-of-cx-2051-in-advanced-solid-tumors-29da25bb-3b07-49ef-8c01-f3588a63f8ee > Record changed: 2026-10-13 # First In Human Study of CX-2051 in Advanced Solid Tumors NCT06265688 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Lead sponsor CytomX Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Start date 2024-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Title and summary **Summary** The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Short title** First In Human Study of CX-2051 in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Official title** An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Dates **Completion date** 2029-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **First posted** 2024-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Registry last updated** 2026-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Primary completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Start date** 2024-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Lead sponsor** CytomX Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Identifiers **Registry ID** NCT06265688 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **ClinicalTrials.gov ID** NCT06265688 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Outcomes ### Primary outcomes 1. Safety and tolerability of CX-2051 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. Time to Treatment Failure (TTF) Timeframe: 60 months TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death. 5. 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. 6. 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. 7. 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/NCT06265688) ## 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 - 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 - Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1 - Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload - Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1 - Elevated baseline laboratory values - Serious concurrent illness - Pregnant or breast feeding - Additional exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Sites - Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Montefiore Medical CenterThe Bronx, United StatesRecruiting - Carolina BioOncology Institute, PLLCHuntersville, United StatesRecruiting - Sarah Cannon Research Institute, LLCNashville, United StatesRecruiting - START - Dallas/Fort WorthFort Worth, United StatesRecruiting - START San Antonio LLCSan Antonio, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06265688) ## Related records ### Drugs (1) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) ### Lead sponsors (1) - [CytomX Therapeutics](https://trialight.com/data/company/cytomx-therapeutics-60926d97-ee88-4ffa-b307-aa0b48974f91.md) ### Conditions (1) - [ADULT syndrome](https://trialight.com/data/condition/adult-syndrome-8aeb5e11-f165-5276-850c-05129a3e72a5.md) Primary condition ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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