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Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy. MEDI3617 is an antibody (a type of protein) that was designed in the laboratory. Preclinical (animal-based) studies suggest that MEDI3617 can slow down the process of new blood vessels being formed in tumors, thereby ?starving? the tumor of nutrients and oxygen needed to keep growing.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Advanced Recurrent Ovarian Tumors
  • drug : MEDI3617
  • drug : MEDI3617 + Bev Q3W Dose Escalation
  • drug : Optional Dose Expansion
  • drug : MEDI3617 + Weekly Pax Dose Escalation
  • drug : MEDI3617 + Pax & Carbo Q3W Dos Esc
  • drug : MEDI3617 + Gem & Carbo Q3W Dos Esc
  • drug : MEDI3617 + Bev Q2W Dose Escalation

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - 99 Years

Inclusion Criteria

- Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists - Patients must be 18 years of age or older - Karnofsky Performance Status ? 70 - Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or < 2 - Adequate organ and marrow function - Using adequate contraceptive measures, be surgically sterile or post-menopausal

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

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