First In Human Study of CX-801 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

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.

Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CX-801

Group Type EXPERIMENTAL

CX-801

Intervention Type DRUG

Investigational drug

CX-801 + pembrolizumab

Group Type EXPERIMENTAL

CX-801

Intervention Type DRUG

Investigational drug

pembrolizumab

Intervention Type DRUG

Standard of Care Therapy

Interventions

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CX-801

Investigational drug

Intervention Type DRUG

pembrolizumab

Standard of Care Therapy

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA®

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
* Adequate organ function

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 immunotherapy 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No