A Study of CDX-585 in Patients With Advanced Malignancies

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2025-05-21

Brief Summary

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

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Detailed Description

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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.

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.

Conditions

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Non-small Cell Lung Cancer Gastric Cancer Head and Neck Cancer Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Bladder Urothelial Carcinoma Colorectal Cancer Esophageal Cancer Hepatic Cancer Renal Cell Carcinoma Cholangiocarcinoma Pancreatic Cancer Other 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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CDX-585

Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance.

Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.

Group Type EXPERIMENTAL

CDX-585

Intervention Type DRUG

CDX-585 is administered by infusion every 2 weeks

Interventions

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CDX-585

CDX-585 is administered by infusion every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
3. Measurable (target) disease by iRECIST.
4. 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.
5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Exclusion Criteria

1. History of severe hypersensitivity reactions to other monoclonal antibodies.
2. Previous treatment with any anti-ILT4 antibody.
3. Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy, including in the adjuvant setting.
4. 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.
5. 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.
6. Thrombotic events within the last six months prior to study treatment
7. Active, untreated central nervous system metastases.
8. Active autoimmune disease or documented history of autoimmune disease.
9. History of (non-infectious) pneumonitis or has current pneumonitis.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No