MedTrace Logo

Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer

NCT02270372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-05-17

No results posted yet for this study

Summary

This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may also be studied at the recommendation of the safety monitoring committee (SMC).

Conditions

  • Advanced Breast Carcinoma
  • Advanced Ovarian Carcinoma

Interventions

BIOLOGICAL

ONT-10, Varlilumab combination

ONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant. Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27.

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Cascadian Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270372 on ClinicalTrials.gov