Naxitamab + Sacituzumab Govitecan for Breast Cancer

Overseen By Akshara S Raghavendra

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anti-GD2 antibodies, TROP2-targeting drugs

Disqualifiers: Pregnancy, CNS metastases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: Approximately 6 months

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of combining two medicines, naxitamab and sacituzumab govitecan (an antibody-drug conjugate), for treating triple-negative breast cancer (TNBC) that has metastasized. Researchers seek to determine the optimal dose and assess the drugs' combined efficacy. This trial may suit individuals with TNBC who have previously undergone chemotherapy and still have measurable disease. Participants should be willing to provide a sample of their tumor tissue for further study. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have received recent radiotherapy, you may need to adjust your treatment before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sacituzumab govitecan is generally well-tolerated by patients with breast cancer. Common side effects include a low white blood cell count in about 70% of patients, nausea in 62%, and diarrhea in 54%. These reactions are typical, but most patients manage them well.

The effects of combining naxitamab with sacituzumab govitecan are still under study. This trial is in the early stages (Phase 1 and 2), focusing on understanding safety and determining the best dosage. While some safety information is available, the complete safety profile is still being developed.

Prospective participants should know that sacituzumab govitecan has been studied and is considered safe for certain breast cancer treatments. The combination with naxitamab is new, so researchers are closely monitoring its effects to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Naxitamab and Sacituzumab Govitecan for breast cancer because they offer a unique approach compared to traditional therapies like chemotherapy, hormone therapy, or HER2-targeted treatments. Naxitamab is an antibody that specifically targets GD2, a molecule often found on cancer cells, potentially providing a more precise attack on the tumor. Sacituzumab Govitecan is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells, which may reduce damage to healthy cells and enhance effectiveness. Together, these treatments could offer a powerful combination, aiming to improve outcomes with a targeted strike against breast cancer cells.

What evidence suggests that this trial's treatments could be effective for metastatic triple-negative breast cancer?

Research has shown that sacituzumab govitecan may effectively treat metastatic triple-negative breast cancer (TNBC). In one study, patients taking sacituzumab govitecan lived for a median of 12.1 months, compared to 6.7 months with other treatments. Another study found that the cancer did not worsen for a median of 4.8 months. In this trial, participants will receive a combination of naxitamab and sacituzumab govitecan to evaluate if this combination can enhance treatment effectiveness. Although less information exists on naxitamab for TNBC, researchers are investigating its potential to improve outcomes when used with sacituzumab govitecan. The aim is to determine if this combination can lead to better results for patients with TNBC that has spread. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinton Yam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic triple-negative breast cancer, which means their cancer has spread beyond the original site. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

I am 18 or older and can understand and sign a consent form.

Willingness to provide archival tumor tissue for correlative studies associated with this trial

Life expectancy of at least 3 months

Exclusion Criteria

Uncontrolled hypertension, defined as a consistently elevated systolic blood pressure of >160 mmHg despite optimal medical management

I have received a transplant from another person.

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

Approximately 6 months

Visits every 21 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Naxitamab
• Sacituzumab Govitecan

Trial Overview The study is examining the safety and effectiveness of combining two drugs, naxitamab and sacituzumab govitecan, to treat metastatic TNBC. It aims to find the best dosage and observe how well patients respond.

How Is the Trial Designed?

Group I: Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W Experimental Treatment 2 Interventions

Patients 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Y-mAbs Therapeutics

Industry Sponsor

Trials

26

Recruited

1,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07011654

NCT07011654 | Study of Naxitamab and Sacituzumab ... This phase I/II trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165508/

Real-World Clinical Outcomes With Sacituzumab ... The 1-year survival rate was also 43% (95% CI, 33 to 52), with a median PFS of 4.8 months (95% CI, 3.6 to 5.9). Our findings are consistent with ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13181

based therapy in metastatic breast cancer (MBC) in China ... This study aimed to describe treatment patterns, clinical outcomes and safety profile for SG-based therapy and explore the predictors of effectiveness in ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2028485

Sacituzumab Govitecan in Metastatic Triple-Negative ... The median overall survival was 12.1 months (95% CI, 10.7 to 14.0) with sacituzumab govitecan and 6.7 months (95% CI, 5.8 to 7.7) with ...

5. esmoopen.com esmoopen.com/article/S2059-7029(25)01177-9/fulltext

Effectiveness of sacituzumab govitecan and management ... We describe the real-world effectiveness of SG as 2L+ mTNBC treatment and the proportion of patients with neutropenia and its management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11648803/

Safety profile of sacituzumab govitecan in patients with breast ... Most common all-grade adverse events (AEs) were: neutropenia (70 %, 95 % CI, 64–76 %), followed by nausea (62 %, 95 % CI, 55–68 %), diarrhea (54 ...

7. onclive.com onclive.com/view/sacituzumab-govitecan-upholds-efficacy-and-safety-in-real-world-mtnbc-population

Sacituzumab Govitecan Upholds Efficacy and Safety in ... Sacituzumab govitecan demonstrated consistent efficacy and safety in real-world mTNBC patients, with median OS of 11.3 months and PFS of 5.0 ...