Trial Outcomes & Findings for Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer (NCT NCT02776917)

Last Updated: 2025-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Within 4 weeks of starting study treatment

Results posted on

2025-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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. Cirmtuzumab + Paclitaxel: 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.
Overall Study STARTED	23
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Cirmtuzumab + Paclitaxel: 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.
Overall Study Screen failures. One subject ended treatment early due to disease related symptoms	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cirmtuzumab + Paclitaxel n=16 Participants 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. Cirmtuzumab + Paclitaxel: 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.
Age, Continuous	52.56 years STANDARD_DEVIATION 11.34 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 4 weeks of starting study treatment

Outcome measures

Outcome measures
Measure	Cirmtuzumab + Paclitaxel n=16 Participants 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. Cirmtuzumab + Paclitaxel: 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.
Dose-limiting Toxicities During the First 4 Weeks of Treatment	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cirmtuzumab + Paclitaxel n=16 Participants 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. Cirmtuzumab + Paclitaxel: 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.
Number of Participants With Treatment-emergent Adverse Events	16 participants

SECONDARY outcome

Timeframe: 55 weeks

Response and progression were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.

Outcome measures

Outcome measures
Measure	Cirmtuzumab + Paclitaxel n=16 Participants 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. Cirmtuzumab + Paclitaxel: 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.
Objective Tumor Response Rate	6 Participants

SECONDARY outcome

Timeframe: 12 months

The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1

Outcome measures

Outcome measures
Measure	Cirmtuzumab + Paclitaxel n=16 Participants 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. Cirmtuzumab + Paclitaxel: 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.
Best Tumor Response Rate	12 Participants

Adverse Events

Cirmtuzumab + Paclitaxel

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cirmtuzumab + Paclitaxel n=16 participants at risk 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. Cirmtuzumab + Paclitaxel: 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.
General disorders Back Pain	6.2% 1/16 • Number of events 1 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Joint range of motion decreased cervical spine	6.2% 1/16 • Number of events 1 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Immune system disorders Flu like symptoms	6.2% 1/16 • Number of events 1 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Colonic hemorrhage	6.2% 1/16 • Number of events 1 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.

Other adverse events

Other adverse events
Measure	Cirmtuzumab + Paclitaxel n=16 participants at risk 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. Cirmtuzumab + Paclitaxel: 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.
Blood and lymphatic system disorders Anemia	12.5% 2/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Cardiac disorders Supraventricular tachycardia	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Eye disorders Blurred vision	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Eye disorders Dry eye	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Eye disorders Eye pain	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Bloating	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Constipation	56.2% 9/16 • Number of events 12 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Diarrhea	43.8% 7/16 • Number of events 11 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Dyspepsia	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Gastroesophageal reflux disease	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Nausea	68.8% 11/16 • Number of events 14 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Gastrointestinal disorders Vomiting	25.0% 4/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Chills	18.8% 3/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Fatigue	81.2% 13/16 • Number of events 14 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Fever	25.0% 4/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Flu like symptoms	31.2% 5/16 • Number of events 8 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders General disorders and administration site conditions - Other, specify	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Non-cardiac chest pain	12.5% 2/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
General disorders Pain	37.5% 6/16 • Number of events 12 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Infections and infestations Infections and infestations - Other, specify	12.5% 2/16 • Number of events 5 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Infections and infestations Upper respiratory infection	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Infections and infestations Urinary tract infection	12.5% 2/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Investigations Neutrophil count decreased	25.0% 4/16 • Number of events 7 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Musculoskeletal and connective tissue disorders Arthralgia	18.8% 3/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 4/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Nervous system disorders Dizziness	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Nervous system disorders Headache	18.8% 3/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Nervous system disorders Peripheral motor neuropathy	37.5% 6/16 • Number of events 7 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Nervous system disorders Peripheral sensory neuropathy	43.8% 7/16 • Number of events 8 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Psychiatric disorders Anxiety	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Psychiatric disorders Insomnia	50.0% 8/16 • Number of events 8 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Renal and urinary disorders Urinary retention	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 3/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.8% 3/16 • Number of events 5 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Respiratory, thoracic and mediastinal disorders Nasal congestion	18.8% 3/16 • Number of events 4 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Skin and subcutaneous tissue disorders Alopecia	37.5% 6/16 • Number of events 6 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Skin and subcutaneous tissue disorders Dry skin	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Skin and subcutaneous tissue disorders Nail discoloration	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.5% 2/16 • Number of events 3 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.
Vascular disorders Flushing	12.5% 2/16 • Number of events 2 • Adverse events were monitored weekly from the beginning of study procedures to 30 days following the last administration of study treatment or start of new anti-cancer therapy. The median time on study was 16 weeks with a median number of cycles ranging from 1 to 14.

Additional Information

Barbara Parker, MD

University of California, San Diego

Phone: (858) 657-6100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place