Overview
The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors.
Description
The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.
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
- 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
- Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
- Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
- Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
- Elevated baseline laboratory values
- Serious concurrent illness
- Pregnant or breast feeding
- Additional exclusion criteria may apply