Overview

A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies

Status:
Not yet recruiting
Trial end date:
2026-02-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celldex Therapeutics
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.