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

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

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

Conditions2

Interventions2

Locations3 sites

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