Esophageal Cancer Clinical Trial

A Study of CDX-585 in Patients With Advanced Malignancies

Summary

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

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Full Description

This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study.

Approximately 130 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
Measurable (target) disease by iRECIST.
If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment.
Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Key Exclusion Criteria:

History of severe hypersensitivity reactions to other monoclonal antibodies.
Previous treatment with any anti-ILT4 antibody.
Patients who have received more than 1 anti-PD-1 or anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1 targeted therapy, including in the adjuvant setting.
Prior anti-PD-L1 based therapy within 12 weeks and prior anti-PD-1 based therapy within four weeks to the planned start of study treatment.
Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least one year to be allowed to enroll.
Thrombotic events within the last six months prior to study treatment
Active, untreated central nervous system metastases.
Active autoimmune disease or documented history of autoimmune disease.
History of (non-infectious) pneumonitis or has current pneumonitis.

There are additional criteria your study doctor will review with you to confirm eligibility.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT05788484

Recruitment Status:

Recruiting

Sponsor:

Celldex Therapeutics

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There are 4 Locations for this study

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George Washington University Cancer Center
Washington District of Columbia, 20037, United States More Info
Emilie Ginovker
Contact
[email protected]
AdventHealth Celebration
Celebration Florida, 34747, United States More Info
Amy Whitaker
Contact
[email protected]
Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States More Info
Phase 1 Clinical Research Team
Contact
[email protected]
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Tara Foote
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT05788484

Recruitment Status:

Recruiting

Sponsor:


Celldex Therapeutics

How clear is this clinincal trial information?

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