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A Study of CDX-585 in Patients With Advanced Malignancies

Primary Purpose

Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CDX-585
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring LILRB2, CD85d, ILT-4, PD1, Bi-Specific, Immunotherapy, Solid tumor Malignancies, Dose escalation, Immunological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-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.

Sites / Locations

  • George Washington University Cancer CenterRecruiting
  • AdventHealth CelebrationRecruiting
  • Perlmutter Cancer Center at NYU Langone HealthRecruiting
  • Providence Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDX-585

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.
Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.

Secondary Outcome Measures

Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
The rates of drug-related adverse events will be summarized and evaluated.
Objective Response Rate
The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Clinical Benefit Rate
The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Duration of Response
The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Progression-free Survival
The time from start of study drug to time of progression or death, whichever occurs first
Overall Survival
The time from start of study drug to death
Pharmacokinetic Evaluation
CDX-585 serum concentrations will be measured at specified visits
Immunogenicity Evaluation
Samples will be obtained for assessment of human anti-CDX-585

Full Information

First Posted
March 15, 2023
Last Updated
October 6, 2023
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05788484
Brief Title
A Study of CDX-585 in Patients With Advanced Malignancies
Official Title
A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
LILRB2, CD85d, ILT-4, PD1, Bi-Specific, Immunotherapy, Solid tumor Malignancies, Dose escalation, Immunological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDX-585
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CDX-585
Intervention Description
CDX-585 is administered by infusion every 2 weeks
Primary Outcome Measure Information:
Title
Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
Description
The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.
Time Frame
Approximately 12 months
Title
Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
Description
The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
Description
The rates of drug-related adverse events will be summarized and evaluated.
Time Frame
From first dose through 90 days after last dose
Title
Objective Response Rate
Description
The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Time Frame
Assessed up to approximately 1-3 years.
Title
Clinical Benefit Rate
Description
The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Time Frame
Assessed up to approximately 1-3 years.
Title
Duration of Response
Description
The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Time Frame
First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
Title
Progression-free Survival
Description
The time from start of study drug to time of progression or death, whichever occurs first
Time Frame
Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 years)
Title
Overall Survival
Description
The time from start of study drug to death
Time Frame
The time from start of study drug to death from any cause (up to approximately 1-3 years)
Title
Pharmacokinetic Evaluation
Description
CDX-585 serum concentrations will be measured at specified visits
Time Frame
Prior to, during, and at multiple time points after doses 1-4. Prior to every other dose from fifth dose, and at 30 and 90 days post last dose of study treatment
Title
Immunogenicity Evaluation
Description
Samples will be obtained for assessment of human anti-CDX-585
Time Frame
Prior to the first three doses and every other dose from the fifth dose of study treatment, then 30 and 90 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celldex Therapeutics
Phone
(844) 723-9363
Email
info@celldex.com
Facility Information:
Facility Name
George Washington University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niharika Dar
Email
Niharika.Dar@email.gwu.edu
Facility Name
AdventHealth Celebration
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Whitaker
Email
amy.whitaker@adventhealth.com
Facility Name
Perlmutter Cancer Center at NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phase 1 Clinical Research Team
Email
PCC-Phase1@nyulangone.org
Facility Name
Providence Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Foote
Email
canrsrchstudies@providence.org

12. IPD Sharing Statement

Learn more about this trial

A Study of CDX-585 in Patients With Advanced Malignancies

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