A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With 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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2025-06-04

Brief Summary

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The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.

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Detailed Description

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This is a first-in-human study evaluating the safety, tolerability, and activity of CX-904, a conditionally activated T-cell bispecific to EGFR and CD3. The design includes single patient cohorts and a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.

Conditions

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Solid Tumors

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-904

Group Type EXPERIMENTAL

CX-904

Intervention Type DRUG

CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.

Interventions

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CX-904

CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
* Measurable disease per RECIST 1.1
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate baseline laboratory values
* Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-904.

Exclusion Criteria

* History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence
* Screening electrocardiogram demonstrating a mean QTcF value \> 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) \< 50%
* Serious concurrent illness
* History of or current active autoimmune diseases
* History of myocarditis regardless of the cause
* Pregnant or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No