A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers

• Status: Completed
• Trial end date: 2017-10-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celldex Therapeutics
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the study:

1. 18 years of age or older.

2. Body Weight ≤ 120 kg.

3. Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer. For the solid tumor expansion cohorts, enrollment is limited to the following solid tumors: melanoma and renal cell carcinoma.

4. Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options, with the following exception: melanoma patients enrolled in the expansion phase must have previously received ipilimumab and, for patients with the BRAF V600E mutation, vemurafenib, or have been offered such therapies and refused, and patients must have progressive disease subsequent to previous therapies.

5. Measurable or evaluable disease.

6. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.

7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.

8. Have little or no side effects remaining from prior cancer therapies.

9. Provide written informed consent.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the study:

1. Known prior primary or metastatic brain or meningeal tumors.

2. Receiving treatment with immunosuppressive agents, including any systemic steroids.

3. Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C.

4. Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency.

5. Women who are pregnant or lactating.

6. Prior allogeneic bone marrow transplant.

7. Autologous bone marrow transplant within 100 days of first dosing.

8. Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type).

9. Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing.