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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Safety and tolerability of CX-801 as monotherapy and combination therapy — 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
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
Trial sites (5)
Facility
City
Region
Status
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.