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

Primary Outcome 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 [Time Frame: Approximately 12 months]
  • 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. [Time Frame: Approximately 6 months]
  • The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.

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.