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Sacituzumab govitecan

Phase 1

Metastatic Triple-Negative Breast Cancer | Small molecule | Oncology |Y-mAbs Therapeutics, Inc.|Last Updated: Apr 16, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Sacituzumab govitecan · 1 trial · 1 indication

Phase 1 1
NCT07011654Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)Metastatic Triple-Negative Breast Cancer
RECRUITING31 Analytics
PHASE1RECRUITING
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Metastatic Triple-Negative Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Adverse Events (AEs)
Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment with Naxitamab and Sacituzumab Govitecan IV Q3WEXPERIMENTALPatients receive naxitamab IV on days 2, 4, and 6 of cycles 1-8 and sacituzumab govitecan IV days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
Sacituzumab govitecanDRUGGiven by IV
NaxitamabDRUGGiven by IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria * Male and female participants aged 18 years or older and able to understand and give written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (for the phase I portion of the study) and ECOG performance status of 0-2 (for the phase I...

Countries:United States
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Frequently asked questions about Sacituzumab govitecan

What is Sacituzumab govitecan used for in metastatic triple-negative breast cancer?

Sacituzumab govitecan is being studied for the treatment of metastatic triple-negative breast cancer (TNBC). It is currently in Phase 1 clinical development as an investigational therapy for this condition. The drug is being evaluated in a clinical trial enrolling patients with metastatic TNBC.

What does Sacituzumab govitecan target?

Sacituzumab govitecan is an antibody-based therapy, classified as a -mab (antibody). It is being studied in metastatic triple-negative breast cancer. The specific molecular target is not disclosed in the available information.

Who is developing Sacituzumab govitecan?

Sacituzumab govitecan is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol YMAB. The company is conducting a Phase 1 clinical trial of the drug in patients with metastatic triple-negative breast cancer.

What phase is Sacituzumab govitecan in?

Sacituzumab govitecan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with metastatic triple-negative breast cancer.

What clinical trials is Sacituzumab govitecan in?

Sacituzumab govitecan is being studied in a Phase 1 clinical trial with the identifier NCT07011654. The trial is titled 'Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)' and is currently recruiting participants in the United States.

Is Sacituzumab govitecan the same as Naxitamab?

Sacituzumab govitecan is not the same as Naxitamab. They are distinct drugs being studied together in a combination clinical trial for metastatic triple-negative breast cancer. The trial evaluates both agents in patients with this condition.