First In Human Study of CX-801 in Advanced Solid Tumors (NCT06462794) | Clinical Trial Compass
RecruitingPhase 1
First In Human Study of CX-801 in Advanced Solid Tumors
United States121 participantsStarted 2024-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of CX-801 as monotherapy and combination therapy