Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors

NCT02225002 | Completed Phase 1 DMC

• 1 other identifier: UPCC 10903
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell lung cancers. In preclinical models, activation of CD40 results in increased antigen presentation and induction of apoptosis. CD40 is also expressed on antigen presenting cells (APCs) (B cells, dendritic cells, monocytes) and is a key regulator of both cellular and humoral immune responses. Activation of CD40 by CP-870,893, an agonistic anti-CD40 monoclonal antibody, enhances host immune responses and abrogates the growth of tumors independently of the expression of CD40 on tumor cells. Therefore, it is hypothesized that therapeutic intervention with CP-870,893 may be beneficial to a large number of cancer patients either through an immunomodulatory effect or through a direct effect on CD40-positive tumor cells.

Conditions

Advanced Solid Tumors

Keywords

relapsed; refractory to standard therapy; no effective therapy exists

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  2 years

Interventions

CP-870,893 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at least 18 years old with advanced solid tumors relapsed or refractory to standard therapy or for whom no effective therapy exists;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
• Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
• White blood cell (WBC) count \>3000 cells/μL without growth factor support;
• Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
• Platelets \>100,000/μL without growth factor support; and
• Hemoglobin ≥10 g/dL;
• D-dimer WNL;
• Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
• Total bilirubin \<1.5 times the upper limit of normal (ULN);
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<2.5 × ULN;
• Creatinine clearance (CLcr, measured or calculated) \>80 mL/min; and
• Life expectancy of at least 12 weeks;
• Fully recovered from the acute effects of prior cancer therapy: 4 weeks for chemotherapy (8 weeks for mitomycin C or nitrosoureas), 10 days for prior palliative radiation therapy or hormonal therapy, and 4 weeks for prior immunotherapy or other biologic therapy; and
• Signed written informed consent.

You may not qualify if:

• Previously treated with any other agent that targets CD40;
• Concurrent treatment with any anticancer agent;
• History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory boweldisease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
• Treatment with any other investigational therapy within 4 weeks prior to baseline;
• History (within the previous year) of congestive heart failure, stroke, or myocardial infarction;
• Patients with known hereditary or acquired coagulopathies (eg. hemophilia, von Willebrand's disease, cancer-associated DIC, abnormal D-dimer);
• Patients with known brain metastases. Patients with clinical evidence suggestive of new brain metastases prior to enrollment are excluded if brain metastases have not been ruled out via CT or MRI. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable;
• Patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline;
• Known sensitivity to immunomodulating agents or monoclonal antibodies;
• Alcohol abuse or illicit drug use within 12 months of enrollment;
• History of serum creatinine ≥2 mg/dL for any duration and for any reason;
• Patients, other than menstruating females, with urine dipstick 1+ or more positive for blood or 2+ or more positive for protein;
• Patients with clinically significant presence of granular or cellular casts in centrifuged urine sediment;
• Patients with renal carcinoma or renal metastases;
• Patients that have had a partial or complete nephrectomy;

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Recurrence

Interventions

selicrelumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Vonderheide, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 25, 2014
• Study Start: January 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (1)