Disitamab Vedotin for HER2-Positive Cancer

Recruiting at 160 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Seagen Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called disitamab vedotin (DV) on patients with advanced or metastatic cancers that have a specific marker called HER2. The drug works by finding and attaching to cancer cells, then delivering a substance to kill them. The study aims to see if DV is effective and safe for these patients. Disitamab vedotin is an antibody-drug conjugate designed for targeting HER2 that has been approved for urothelial carcinoma and gastric cancer.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have had prior treatment with an MMAE-containing agent and should not have a known hypersensitivity to any excipient in disitamab vedotin. It's best to discuss your current medications with the trial team.

What data supports the idea that Disitamab Vedotin for HER2-Positive Cancer is an effective drug?

The available research shows that Disitamab Vedotin is effective in treating various cancers, including gastric cancer, urothelial carcinoma, and HER2 low-expressing breast cancer. It has been shown to improve clinical outcomes and has a wider therapeutic window with less toxicity compared to other HER2-targeting drugs. In a case of lung adenocarcinoma, a patient experienced significant improvement in lung and brain lesions after treatment with Disitamab Vedotin. Additionally, it has been approved in China for treating advanced gastric cancer, indicating its effectiveness. ^{1 2 3 4 5}

What safety data is available for Disitamab Vedotin?

Disitamab Vedotin, also known as RC48-ADC, has been evaluated in various studies for its safety and efficacy. It has been approved in China for HER2-overexpressing gastric cancer and is being developed for other cancers like urothelial, biliary tract, and non-small cell lung cancer. Compared to conventional HER2-targeting agents, Disitamab Vedotin is noted for having a wider therapeutic window and less toxicity to normal tissues. Phase II trials and real-world studies have shown its efficacy in metastatic urothelial carcinoma, and it is being explored in combination with immunotherapy. However, there is limited clinical evidence for its use in lung adenocarcinoma, although case reports suggest potential benefits. ^{1 2 3 4 5}

Is the drug Disitamab Vedotin a promising treatment for HER2-Positive Cancer?

Yes, Disitamab Vedotin is a promising drug for HER2-Positive Cancer. It has shown effectiveness in treating various cancers like gastric, urothelial, and breast cancer by targeting the HER2 protein, which is often overactive in these cancers. It has been approved for use in some countries and is being tested in others, showing potential to improve patient outcomes. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors like head and neck, lung, endometrial, or ovarian cancer that have a HER2 marker. They must have tried platinum-based therapy without success and can't have had too many prior treatments. People with untreated brain metastases, previous HER2-targeted ADC treatment, recent other cancers, or sensitivity to DV ingredients cannot join.

Inclusion Criteria

I have advanced head and neck cancer that has worsened after platinum therapy.

I have ovarian cancer that is advanced, platinum-resistant, and I've had 4 or fewer chemotherapy treatments.

I have NSCLC that's advanced or spread and didn't respond well to platinum therapy or PD(L)1 inhibitors.

Exclusion Criteria

I have brain or spinal cord metastasis that hasn't been treated.

Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin

I haven't had another type of invasive cancer in the last 2 years.

Treatment Details

Interventions

• Disitamab Vedotin (Monoclonal Antibodies)

Trial Overview The study tests disitamab vedotin (DV), an experimental antibody-drug conjugate designed to target and kill cancer cells in tumors expressing the HER2 marker. Participants will receive DV every two weeks to evaluate its effectiveness against various solid tumors and assess its safety profile.

Participant Groups

Group I: Ovarian cancer Experimental Treatment 1 Intervention

Disitamab vedotin monotherapy

Group II: Non-small cell lung cancer Experimental Treatment 1 Intervention

Disitamab vedotin monotherapy

Group III: Head and neck cancer Experimental Treatment 1 Intervention

Disitamab vedotin monotherapy

Group IV: Endometrial cancer Experimental Treatment 1 Intervention

Disitamab vedotin monotherapy

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Findings from Research

Disitamab vedotin (RC48), an HER2-targeted antibody-drug conjugate, shows enhanced tumor suppression and improved antitumor immunity when combined with PD-1/PD-L1 immune checkpoint inhibitors in a human HER2-expressing breast cancer model.

The combination therapy not only led to significant tumor rejection but also promoted the formation of immunological memory, providing long-lasting protection against tumor recurrence in treated mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A HER2 target antibody drug conjugate combined with anti-PD-(L)1 treatment eliminates hHER2+ tumors in hPD-1 transgenic mouse model and contributes immune memory formation. Huang, L., Wang, R., Xie, K., et al.[2022]

Disitamab vedotin, an antibody-drug conjugate targeting HER2, showed promising results in a 52-year-old man with advanced lung adenocarcinoma after previous treatments failed, leading to improvements in both lung and brain lesions.

This case suggests that Disitamab vedotin could be a valuable treatment option for patients with HER2 IHC2+ lung adenocarcinoma, providing a new avenue for therapy in this specific cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Disitamab Vedotin in a heavily pre-treated HER2 positive lung adenocarcinoma patient: case report and literature review. Qi, X., Guo, J., Zhou, X., et al.[2022]

Disitamab vedotin, an antibody-drug conjugate targeting HER2, received its first approval in China for treating HER2-overexpressing locally advanced or metastatic gastric cancer after patients have undergone at least two chemotherapy regimens.

The drug is also being explored for use in other solid tumors, including urothelial cancer and various types of breast cancer, indicating its potential as a versatile treatment option in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disitamab Vedotin: First Approval. Deeks, ED.[2023]

Disitamab vedotin (RC48) is a promising antibody-drug conjugate that targets HER2, showing a wider therapeutic window and reduced toxicity compared to traditional HER2-targeting treatments.

RC48 is being investigated for its effectiveness in various cancers, particularly gastric and gastroesophageal junction cancers, indicating its potential as a versatile treatment option in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disitamab vedotin, a novel HER2-directed antibody-drug conjugate in gastric cancer and other solid tumors. Hu, Y., Zhu, Y., Wei, X., et al.[2022]

In a study of 36 patients with locally advanced or metastatic urothelial carcinoma, RC48-ADC (disitamab vedotin) demonstrated promising efficacy, with a median progression-free survival (PFS) of 5.4 months and a 1-year overall survival (OS) rate of 79.6%.

Combining RC48 with immunotherapy significantly improved median PFS to 8.5 months compared to 5.4 months for RC48 alone, indicating that this combination may enhance treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HER2-targeting antibody-drug conjugate RC48 alone or in combination with immunotherapy for locally advanced or metastatic urothelial carcinoma: a multicenter, real-world study. Chen, M., Yao, K., Cao, M., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A HER2 target antibody drug conjugate combined with anti-PD-(L)1 treatment eliminates hHER2+ tumors in hPD-1 transgenic mouse model and contributes immune memory formation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of Disitamab Vedotin in a heavily pre-treated HER2 positive lung adenocarcinoma patient: case report and literature review. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Disitamab Vedotin: First Approval. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Disitamab vedotin, a novel HER2-directed antibody-drug conjugate in gastric cancer and other solid tumors. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

HER2-targeting antibody-drug conjugate RC48 alone or in combination with immunotherapy for locally advanced or metastatic urothelial carcinoma: a multicenter, real-world study. [2023]