Brief Title: CDX-585 in Patients With Advanced Malignancies

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• 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

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Celldex Therapeutics

Phone: (844) 723-9363

Email: info@celldex.com

LOCATION