Breast NeoplasmsPhase 1NCT02776917
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
A Phase 1 study testing Cirmtuzumab + Paclitaxel in people with Breast Neoplasms, run by Barbara Parker, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Cirmtuzumab + Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 26 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed, metastatic or locally advanced surgically unresectable, HER2 negative breast cancer. HER2 status should reflect the most recent biopsy results. Note: HER2 negative breast cancer is defined according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2013 for HER2 testing performed in a CLIA-certified laboratory.
- ER/PR negative (<10% of cells staining for ER or PR) breast cancer or have ER/PR positive (≥10% of cells staining for ER or PR) breast cancer that has exhausted standard endocrine therapy and/or in the opinion of the treating oncologist, warrants cytotoxic chemotherapy.
- Measurable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI). Patients with bone only disease will be eligible if disease is considered measurable and a soft tissue component is present and can be biopsied..
- There is no limit to prior lines of therapy, but patients must not have received prior taxane chemotherapy in the metastatic setting.
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined below:
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- Absolute Neutrophil Count ≥ 1.0 x 10^9/L
- Platelet count ≥ 100,000 /μL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal
- AST and ALT ≤ 3 x upper limit of normal
- Serum creatinine ≤ 2 x upper limit of normal OR Creatinine clearance > 40 ml/min/1.73 m^2
- Women of child-bearing potential and male subjects who are sexually active with a woman of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months following last infusion of cirmtuzumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Existing neuropathy must be no greater than Grade 1.
- No concurrent antibody therapy can be planned with the exception of denosumab for use in bone metastasis.
- CNS metastases are allowed as long as the metastases are asymptomatic, have been treated with radiation, and have been stable for > 6 weeks off steroids.
Who cannot join
- Patient is currently receiving chemotherapy or has received another chemotherapy within 5 half-lives, radiotherapy or immunotherapy within 2 weeks prior to study treatment initiation.
- Patient has known, untreated and/or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Patient had disease that was refractory to paclitaxel in the neoadjuvant setting and/or developed metastatic breast cancer within 6 months of neoadjuvant or adjuvant taxane chemotherapy.
- Patient has had major surgery within 3 weeks prior to enrollment.
- Patient has severe and/or uncontrolled medical disease(s) (i.e., myocardial infarction within 6 months of study, CKD stage IV or above, severe chronic pulmonary disease or active infection).
- The patient has known acute or chronic hepatitis B or C.
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- The patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel.
- The patient has a history of another malignancy within 2 years prior to study entry, except curatively treated non-melanotic skin cancer, cervical carcinoma in situ or stage I colon cancer.
- Patient has a history of non-compliance or other medical illness that would preclude compliance with study procedures.
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patient has severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease
- Patient is pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer
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).
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Cirmtuzumab + Paclitaxel
- Keywords
- metastatic breast cancer, locally advanced, unresectable breast cancer, HER2/NEU negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cirmtuzumab + PaclitaxelDrug
Also called UC-961 or Zilovertamab, Taxol
Cirmtuzumab and paclitaxel may be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cirmtuzumab + Paclitaxel | Experimental | 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. Receives: Drug: Cirmtuzumab + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicities During the First 4 Weeks of 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.
Measured: Within 4 weeks of starting study treatment
Secondary outcomes (3)
Number of Participants With Treatment-emergent Adverse Events
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.
Measured: 55 weeks
Objective Tumor Response Rate
Response and progression were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Measured: 55 weeks
Best Tumor Response Rate
The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start15 Aug 2018
- Primary completion13 Jul 2021
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Parker, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Oncternal Therapeutics, Inc
- Responsible party
- Sponsor-investigator, Barbara Parker, MD, University of California, San Diego
- Investigators
- Barbara Parker, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776917
- Sponsor's protocol ID
- 160178
- Status last verified
- Aug 2025
- First submitted
- 16 May 2016
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shatsky RA, Batra-Sharma H, Helsten T, Schwab RB, Pittman EI, Pu M, Weihe E, Ghia EM, Rassenti LZ, Molinolo A, Cabrera B, Breitmeyer JB, Widhopf GF 2nd, Messer K, Jamieson C, Kipps TJ, Parker BA. A phase 1b study of zilovertamab in combination with paclitaxel for locally advanced/unresectable or metastatic Her2-negative breast cancer. Breast Cancer Res. 2024 Feb 26;26(1):32. doi: 10.1186/s13058-024-01782-0.
PubMed 38408999
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer
- ClinicalTrials.gov ID
- NCT02776917
- Acronym / sponsor ID
- 160178
- Conditions
- Breast Neoplasms
- Keywords
- metastatic breast cancer, locally advanced, unresectable breast cancer, HER2/NEU negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Barbara Parker, MDUniversity, hospital or other
- Collaborators
- Oncternal Therapeutics, Inc
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirmtuzumab + Paclitaxel | Experimental | Drug: Cirmtuzumab + PaclitaxelCirmtuzumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Biopsy-confirmed, metastatic or locally advanced surgically unresectable, HER2 negative breast cancer. HER2 status should reflect the most recent biopsy results. Note: HER2 negative breast cancer is defined according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2013 for HER2 testing performed in a CLIA-certified laboratory.
- ER/PR negative (<10% of cells staining for ER or PR) breast cancer or have ER/PR positive (≥10% of cells staining for ER or PR) breast cancer that has exhausted standard endocrine therapy and/or in the opinion of the treating oncologist, warrants cytotoxic chemotherapy.
- Measurable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI). Patients with bone only disease will be eligible if disease is considered measurable and a soft tissue component is present and can be biopsied..
- There is no limit to prior lines of therapy, but patients must not have received prior taxane chemotherapy in the metastatic setting.
- ECOG Performance Status ≤ 2.
Key exclusion criteria (12 listed)
- Patient is currently receiving chemotherapy or has received another chemotherapy within 5 half-lives, radiotherapy or immunotherapy within 2 weeks prior to study treatment initiation.
- Patient has known, untreated and/or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Patient had disease that was refractory to paclitaxel in the neoadjuvant setting and/or developed metastatic breast cancer within 6 months of neoadjuvant or adjuvant taxane chemotherapy.
- Patient has had major surgery within 3 weeks prior to enrollment.
- Patient has severe and/or uncontrolled medical disease(s) (i.e., myocardial infarction within 6 months of study, CKD stage IV or above, severe chronic pulmonary disease or active infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cirmtuzumab + PaclitaxelAlso: UC-961 or Zilovertamab, TaxolCirmtuzumab and paclitaxel may be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity. | Drug | Cirmtuzumab + Paclitaxel |
Primary outcome
Dose-limiting Toxicities During the First 4 Weeks of Treatment
Time frame: 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.
3 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events
Time frame: 55 weeks
Objective Tumor Response Rate
Time frame: 55 weeks
Best Tumor Response Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38408999Shatsky RA, Batra-Sharma H, Helsten T, Schwab RB, Pittman EI, Pu M, Weihe E, Ghia EM, Rassenti LZ, Molinolo A, Cabrera B, Breitmeyer JB, Widhopf GF 2nd, Messer K, Jamieson C, Kipps TJ, Parker BA. A phase 1b study of zilovertamab in combination with paclitaxel for locally advanced/unresectable or metastatic Her2-negative breast cancer. Breast Cancer Res. 2024 Feb 26;26(1):32. doi: 10.1186/s13058-024-01782-0.
- PubMedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Parker, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cirmtuzumab + Paclitaxel in people with Breast Neoplasms, run by Barbara Parker, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities During the First 4 Weeks of Treatment (time frame: Within 4 weeks of starting study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.