Clinical trial NCT05788484: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Approximately 12 months
measure: Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
timeFrame: From first dose through 90 days after last dose
measure: Objective Response Rate
timeFrame: Assessed up to approximately 1-3 years.
measure: Clinical Benefit Rate
timeFrame: Assessed up to approximately 1-3 years.
measure: Duration of Response
timeFrame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
measure: Progression-free Survival
timeFrame: Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 years)
measure: Overall Survival
timeFrame: The time from start of study drug to death from any cause (up to approximately 1-3 years)
measure: Pharmacokinetic Evaluation
timeFrame: 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
measure: Immunogenicity Evaluation
timeFrame: 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
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Cancer Center
state: District of Columbia
city: Celebration
country: United States
facility: AdventHealth Celebration
state: Florida
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
Study officials:
References: