A Study of CDX-585 in Patients With Advanced Malignancies

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788484
• Other study ID #: CDX585-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 11, 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Celldex Therapeutics
• Contact: Celldex Therapeutics
• Phone: (844) 723-9363
• Email: info[@]celldex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Key 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.

Related Conditions & MeSH terms

• Bladder Urothelial Carcinoma
• Carcinoma
• Cholangiocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Hepatic Cancer
• Liver Neoplasms
• Neoplasms
• Non-small Cell Lung Cancer
• Other Solid Tumors
• Ovarian Cancer
• Pancreatic Cancer
• Primary Peritoneal Carcinoma
• Renal Cell Carcinoma

Intervention

Drug:
• CDX-585
CDX-585 is administered by infusion every 2 weeks

Locations

Country	Name	City	State
United States	AdventHealth Celebration	Celebration	Florida
United States	Perlmutter Cancer Center at NYU Langone Health	New York	New York
United States	Providence Cancer Institute	Portland	Oregon
United States	George Washington University Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 12 months
Primary	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.	Approximately 6 months
Secondary	Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0	The rates of drug-related adverse events will be summarized and evaluated.	From first dose through 90 days after last dose
Secondary	Objective Response Rate	The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)	Assessed up to approximately 1-3 years.
Secondary	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	Assessed up to approximately 1-3 years.
Secondary	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	First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
Secondary	Progression-free Survival	The time from start of study drug to time of progression or death, whichever occurs first	Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 years)
Secondary	Overall Survival	The time from start of study drug to death	The time from start of study drug to death from any cause (up to approximately 1-3 years)
Secondary	Pharmacokinetic Evaluation	CDX-585 serum concentrations will be measured at specified visits	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
Secondary	Immunogenicity Evaluation	Samples will be obtained for assessment of human anti-CDX-585	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