Disitamab Vedotin for Breast Cancer

Recruiting at 88 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must be taking: Trastuzumab, Pertuzumab, Taxane, others

Must not be taking: MMAE ADCs

Disqualifiers: CNS metastasis, Recent malignancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: Up to approximately 2 years

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of disitamab vedotin, a new treatment for people with advanced, hard-to-treat breast cancer that has spread throughout the body. Participants will receive the treatment through an IV drip every two weeks to evaluate its efficacy and safety. This trial suits those with breast cancer that has spread, tumors with a marker called HER2, and who have already tried other treatments for their advanced cancer. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any systemic anticancer treatment or radiotherapy within 2 weeks before starting the study treatment, and you should have recovered from any side effects of previous therapies.

Is there any evidence suggesting that disitamab vedotin is likely to be safe for humans?

Previous studies have shown disitamab vedotin to be safe for treating breast cancer with varying levels of HER2, a protein present in some tumors. Research indicates no major safety concerns for patients with HER2-positive and HER2-low breast cancer. While some side effects occur, they are generally mild and manageable.

Common side effects include nausea and tiredness, which many patients experience. Standard care can usually manage these side effects. It's important to note that individual reactions vary, so experiences can differ.

Overall, disitamab vedotin appears well-tolerated in patients with advanced breast cancer. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Disitamab vedotin is unique because it targets HER2, a protein that plays a role in the growth of some breast cancers, with a precision-focused approach. Unlike standard treatments like trastuzumab or pertuzumab, which also target HER2, disitamab vedotin is an antibody-drug conjugate, meaning it links a potent chemotherapy drug directly to an antibody that binds to cancer cells. This allows for direct delivery of the drug to cancer cells, potentially sparing healthy cells and reducing side effects. Researchers are excited because this targeted delivery could enhance effectiveness and improve the quality of life for patients with HER2-positive, HER2-low, or HER2-ultra-low breast cancer.

What evidence suggests that disitamab vedotin might be an effective treatment for advanced breast cancer?

Research has shown that disitamab vedotin holds promise for treating advanced breast cancer, particularly in patients with HER2-positive and HER2-low tumors. In earlier studies, about one-third of patients experienced tumor shrinkage, with a 34.40% objective response rate. Additionally, 81.97% of patients achieved disease control, meaning their cancer stopped growing temporarily. This trial will evaluate disitamab vedotin monotherapy across different cohorts, including those with HER2-positive, HER2-low, and hormone receptor-positive or negative breast cancer. This treatment has benefited both hormone receptor-positive and hormone receptor-negative patients, indicating its potential to help a wide range of individuals. Overall, disitamab vedotin appears effective and is considered a promising option for those with difficult-to-treat, advanced breast cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced breast cancer that has spread, expresses HER2, and who have already tried other treatments like trastuzumab, pertuzumab, a taxane, or T-DXd. They should not have had more than three prior systemic cytotoxic therapies. The study excludes those whose tumors don't meet specific HER2 and hormone receptor status criteria.

Inclusion Criteria

My breast cancer is advanced and cannot be removed by surgery.

My cancer is HER2 positive and meets the hormone receptor status for the study.

My cancer's HER2 status was checked following official guidelines.

Exclusion Criteria

I have been treated with ADCs that contain MMAE before.

I have recovered from side effects of my previous treatments.

Known hypersensitivity to any excipient in disitamab vedotin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive disitamab vedotin as an intravenous infusion every 2 weeks until disease progression or other stopping criteria are met

Up to approximately 2 years

Bi-weekly visits (in-person)

Follow-up

Participants have follow-up visits every 6 weeks after stopping treatment, followed by phone calls every 12 weeks

Up to approximately 3 years

Every 6 weeks (in-person), then every 12 weeks (phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Disitamab Vedotin

Trial Overview The trial tests Disitamab Vedotin's safety and effectiveness in treating advanced breast cancer with HER2 expression. Participants will receive the drug through IV every two weeks until they decide to stop due to worsening condition, side effects or personal choice.

How Is the Trial Designed?

Group I: Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low locally advanced or metastatic breast cancer Experimental Treatment 1 Intervention

disitamab vedotin monotherapy

Group II: Cohort 2: HR+, HER2-low locally advanced or metastatic breast cancer Experimental Treatment 1 Intervention

disitamab vedotin monotherapy

Group III: Cohort 1: HER2+ locally advanced or metastatic breast cancer Experimental Treatment 1 Intervention

disitamab vedotin monotherapy

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408859/

Disitamab Vedotin in HER2-Positive and HER2-Low Breast ... This real-world study demonstrates the efficacy of RC48 in both HER2-positive and HER2-low breast cancer. Notably, combination therapy significantly improved ...

2. onclive.com onclive.com/view/disitamab-vedotin-shows-early-efficacy-in-her2-expressing-breast-cancer-with-pam-pathway-abnormalities

Disitamab Vedotin Shows Early Efficacy in HER2- ... Disitamab vedotin demonstrated a 34.40% objective response rate and 81.97% disease control rate in HER2-expressing metastatic breast cancer with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05904964

Study Details | NCT05904964 | Disitamab Vedotin (RC48) ... According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low ...

4. academic.oup.com academic.oup.com/oncolo/article/30/8/oyae304/7902202

Real-world application of disitamab vedotin (RC48-ADC) in ... Recent studies have demonstrated that RC48-ADC offers therapeutic benefits for patients with HER2-positive and HER2-low-expression breast cancer ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cac2.12577

Disitamab vedotin, a HER2‐directed antibody‐drug ... DV demonstrated promising efficacy in HER2-overexpression and HER2-low ABC, with a favorable safety profile at 2.0 mg/kg Q2W.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06966453

NCT06966453 | A Study of Disitamab Vedotin in Adults ... The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395257/

Real-world application of disitamab vedotin (RC48-ADC) in ... RC48-ADC showcases promising efficacy and manageable safety in patients with both HER2-positive and HER2-low-expression mBC. Keywords: breast ...

8. cell.com cell.com/med/pdf/S2666-6340(25)00064-9.pdf

Efficacy and safety of DV in HER2-negative and ... find that disitamab vedotin, a HER2- targeting antibody-drug conjugate, produces promising anti-tumor activity and is well tolerated in heavily ...

9. onclive.com onclive.com/view/disitamab-vedotin-combos-show-efficacy-in-her2-and-her2-low-breast-cancers

Disitamab Vedotin Combos Show Efficacy in HER2+ and ... Disitamab vedotin alone and with ICIs, TKIs, or other antiangiogenic agents had consistent efficacy in patients with HER2-positive or -low breast cancers.