First In Human Study of CX-2051 in Advanced Solid Tumors

CytomX

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor, Adult

Treatments

Drug: CX-2051

Study type

Interventional

Funder types

Industry

Identifiers

NCT06265688

CTMX-2051-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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