NCT06462794 First In Human Study of CX-801 in Advanced Solid Tumors
| NCT ID | NCT06462794 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | CytomX Therapeutics |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2024-08-28 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 121 participants in total. It began in 2024-08-28 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Monika Vainorius, MD
STUDY DIRECTOR
CytomX Therapeutics
Frequently Asked Questions
Who can join the NCT06462794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06462794 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06462794 currently recruiting?
Yes, NCT06462794 is actively recruiting participants. Contact the research team at clinicaltrials@cytomx.com for enrollment information.
Where is the NCT06462794 trial being conducted?
This trial is being conducted at Englewood, United States, Pittsburgh, United States, Nashville, United States, Fort Worth, United States.
Who is sponsoring the NCT06462794 clinical trial?
NCT06462794 is sponsored by CytomX Therapeutics. The principal investigator is Monika Vainorius, MD at CytomX Therapeutics. The trial plans to enroll 121 participants.