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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CX-2051

Group Type EXPERIMENTAL

CX-2051

Intervention Type DRUG

Investigational drug monotherapy

Interventions

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CX-2051

Investigational drug monotherapy

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No