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First-in-Human Study of CX-801 for Advanced Solid Tumors

This study is testing a new investigational drug called CX-801, both by itself and in combination with a standard cancer treatment called pembrolizumab. It's for adults with advanced solid tumors that have continued to grow despite standard treatments. The main goals are to understand the safety and side effects of CX-801, and to find the best dose for future studies. Researchers will also look at how well the treatment works against the cancer. To join, you must have advanced solid tumors that have progressed after standard therapy, and your general health must be good enough to participate. The study is currently unclear about its recruitment status.

Study design
This is a first-in-human study with a planned enrollment of 121 participants. It has two parts: first, to find the maximum safe dose, and then to further evaluate safety and anti-tumor activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The safety and tolerability of CX-801 will be measured for 44 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06462794

First In Human Study of CX-801 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
CytomX Therapeutics
~121 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:CX-801pembrolizumab

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of CX-801 as monotherapy and combination therapy
Measured over 44 months
+1 more outcome measured

Conditions

Solid Tumor, Adult

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NCT06462794

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • SCRI Oncology Partners

    Nashville, Tennesseeno site contact published

    Recruiting

  • START Dallas Fort Worth, LLC

    Fort Worth, Texasno site contact published

    Recruiting

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

    Los Angeles, Californiano site contact published

    Recruiting

  • The Melanoma and Skin Cancer Institute

    Englewood, Coloradono site contact published

    Recruiting

  • University of Pittsburgh Hillman Cancer Center

    Pittsburgh, Pennsylvaniano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Monika Vainorius, MD · STUDY_DIRECTOR · CytomX Therapeutics

Who to contact

Karen Deane
[email protected]
650-515-3185
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Safety and tolerability of CX-801 as monotherapy and combination therapy44 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

  • Determine the recommended Phase 2 dose (RP2D)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