Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer

Phase 1

Completed

Brief Summary: This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).

Detailed Description: * This is a phase 1b, open-label, non-randomized, fixed dose study in patients with HER2 negative metastatic, or locally advanced, unresectable breast cancer.

* Cirmtuzumab and paclitaxel will be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity, as long as the subject is tolerating the drug and does not exhibit disease progression.

* Blood and tissue samples will be collected at pre-specified times to enable pharmacokinetic and correlative studies.

* Adverse events (AE) will be monitored throughout the trial. Reporting of AEs will be in accordance with CTCAE version 4.03.

* Assessment of tumor response will be performed by physical examination and/or by radiographic imaging and according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

* Patients will be assessed at 28 days following the last dose of cirmtuzumab to assess tumor response and at 56 days following the last dose of cirmtuzumab to assess any adverse events and to document any concomitant cancer therapy.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Cirmtuzumab + Paclitaxel	Cirmtuzumab + Paclitaxel	Cirmtuzumab 600 mg is administered intravenously on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. Paclitaxel 80 mg/m\^2 is administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Dose-limiting Toxicities During the First 4 Weeks of Treatment	Within 4 weeks of starting study treatment	Clinically significant adverse events per CTCAE Version 4.03 at least possibly related to cirmtuzumab or the combination of cirmtuzumab and paclitaxel during the first four weeks of investigational treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events	55 weeks	Treatment-emergent adverse events beginning from the start of study treatment to 30 days after study treatment completion or start of new anti-cancer therapy.
Objective Tumor Response Rate	55 weeks	Response and progression were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Best Tumor Response Rate	12 months	The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1

Locations (1): University of California, San Diego
🇺🇸
La Jolla, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States