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Monoclonal Antibodies

Cirmtuzumab + Paclitaxel for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Barbara Parker, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study cirmtuzumab in combination with paclitaxel to see if the combination is safe and has fewer side effects than paclitaxel alone. The study will also look at how well the combination works in treating patients with HER2 negative, metastatic breast cancer.

Who is the study for?

This trial is for adults with HER2 negative, metastatic or locally advanced breast cancer that can't be surgically removed. Participants must have adequate organ function, no more than mild existing neuropathy, and measurable disease confirmed by imaging. They should not have had taxane chemotherapy in the metastatic setting and must agree to use contraception.Check my eligibility

What is being tested?

The study tests combining cirmtuzumab, an experimental monoclonal antibody targeting ROR1 protein on cancer cells, with paclitaxel in patients whose breast cancer has spread and isn't treatable by surgery. The goal is to see if this combination is safe and what side effects it may cause.See study design

What are the potential side effects?

Potential side effects include those common to monoclonal antibodies such as allergic reactions or infusion-related issues, as well as those associated with paclitaxel like hair loss, nerve damage (neuropathy), muscle aches, nausea, vomiting and low blood cell counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The rate of dose-limiting toxicities during the first 4 weeks of treatment

Secondary outcome measures

Best tumor response rate

Measurement of ROR1 expression levels and cancer stem cell populations

Objective tumor response rate

+2 more

Other outcome measures

Assessment of mechanism of action through pharmacokinetic studies

Correlates of PET/CT and cross-sectional imaging

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cirmtuzumab + PaclitaxelExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cirmtuzumab + Paclitaxel

2018

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oncternal Therapeutics, IncIndustry Sponsor

6 Previous Clinical Trials

308 Total Patients Enrolled

Barbara Parker, MDLead Sponsor

Media Library

Cirmtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02776917 — Phase 1

Breast Cancer Research Study Groups: Cirmtuzumab + Paclitaxel

Breast Cancer Clinical Trial 2023: Cirmtuzumab Highlights & Side Effects. Trial Name: NCT02776917 — Phase 1

Cirmtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02776917 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Cirmtuzumab + Paclitaxel be a risk factor for health?

"The safety rating of Cirmtuzumab + Paclitaxel is 1 on the scale from 1 to 3, as this phase 1 trial only has scant data concerning efficacy and security."

Answered by AI

What maladies is Cirmtuzumab + Paclitaxel typically prescribed for?

"Cirmtuzumab in combination with Paclitaxel is a viable therapeutic option for those dealing neoplasm metastasis, kaposi sarcoma and advance directives."

Answered by AI

Are there any previous reports of Cirmtuzumab and Paclitaxel being tested in tandem?

"Currently, 833 studies are being conducted that investigate the combination of Cirmtuzumab and Paclitaxel. Of those active trials, 227 have reached Phase 3 status. Most of these study sites are located in Adelaide, South Australia; however, 45685 venues around the world are conducting research on this treatment regimen."

Answered by AI

Are there vacancies available to participants in this clinical trial?

"At this time, the trial is not accepting new patients. It was initially posted on August 15th 2018 and last modified May 16th 2022. Right now there are 2287 trials enrolling people with breast cancer, plus 833 studies recruiting for Cirmtuzumab + Paclitaxel therapy that prospective participants can consider."

Answered by AI

What is the current sample size for this research project?

"This trial is no longer recruiting volunteers, as the last update was on May 16th 2022. For those who are interested in alternate studies, 2287 clinical trials for breast cancer and 833 involving Cirmtuzumab + Paclitaxel are actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Barbara Parker, MD 2018. "Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02776917.