Study of Magrolimab Combination Therapy to Treat Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Overview

About this study

The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment

The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination with sacituzumab govitecan as
determined by confirmed objective response rate (ORR) by investigator assessment

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion criteria:

- Adequate performance status, hematologic, renal and liver function.

- Measurable disease per RECIST v1.1

- Cohort 1: Individuals with previously untreated unresectable locally advanced or
metastatic TNBC that are considered PD-L1 negative (as determined by an approved test
according to local regulations).

- Cohort 2: Individuals with unresectable, locally advanced or metastatic TNBC who have
received at least 1 and no more than 2 prior lines of therapy in the unresectable,
locally advanced or metastatic setting. Individuals must have been previously treated
with a taxane in any setting. Individuals with tumors that are considered positive for
PD-L1 expression (as determined by an approved test according to local regulations)
must have received an immune checkpoint inhibitor for a prior-line of treatment for
unresectable locally advanced/metastatic TNBC.

Key Exclusion Criteria:

- Positive serum pregnancy test or breastfeeding female.

- Active CNS disease. Individuals with asymptomatic and stable, treated CNS lesions
(radiation and/or surgery and/or other CNS-directed therapy who have not received
corticosteroids for at least 4 weeks) are allowed.

- RBC transfusion dependence, defined as requiring more than 2 units of packed RBC
transfusions during the 4-week period prior to screening. Red blood cell transfusions
are permitted during the screening period and prior to enrollment to meet the
hemoglobin inclusion criteria.

- History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the
last 3 months.

- Prior treatment with CD47 or signal regulatory protein alpha-targeting agents.

- Known inherited or acquired bleeding disorders.

- Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant
therapy.

- Cohort 2 only:

- Individuals with active chronic inflammatory bowel disease (ulcerative colitis,
Crohn disease) and Individuals with a history of bowel obstruction or
gastrointestinal perforation within 6 months of enrollment.

- Individuals who previously received topoisomerase I inhibitors or antibody-drug
conjugates containing a topoisomerase inhibitor.

- High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not
allowed within 2 weeks of Cycle 1 Day 1.

- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a
previously administered agent.

- Note: individuals with any grade neuropathy or alopecia are an exception to
this criterion and will qualify for the study.

- Note: if individuals received major surgery, they must have recovered
adequately from the toxicity and/or complications from the intervention
prior to starting therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/2/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roberto Leon Ferre, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions