SGN-ALPV for Cancer

No longer recruiting at 12 trial locations

Overseen By Seagen Trial Information Support

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Seagen Inc.

Must not be taking: MMAE agents

Disqualifiers: Other malignancy, CNS metastases, neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and side effects of a new drug, SGN-ALPV, in individuals with solid tumor cancers that have spread or cannot be surgically removed. In the first two parts, researchers will determine the appropriate dose of SGN-ALPV. The third part will assess its safety and effectiveness at that dose. Potential participants include those with specific types of cancer, such as ovarian, endometrial, or lung cancer, that are advanced or have recurred after treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that SGN-ALPV is likely to be safe for humans?

Research has shown that SGN-ALPV remains in the early stages of human safety testing. Similar treatments, a type of targeted cancer therapy, have often caused common side effects. These typically include bone marrow issues, affecting blood cell production, and nerve damage. Such effects usually relate to how the drug targets and disrupts cancer cells.

As the drug is in its first testing phase, safety is under close observation, but large human studies have not yet provided extensive data. This phase aims to determine the safest dose. Participants will be closely monitored to manage any side effects as researchers learn more about SGN-ALPV's effects on the body. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SGN-ALPV is unique because it offers a new approach to targeting cancer cells. Unlike standard treatments, which often focus on disrupting cancer cell growth through chemotherapy or radiation, SGN-ALPV works as a monotherapy with a novel mechanism of action. Researchers are excited because it potentially targets cancer cells more precisely, which could mean fewer side effects and a more effective attack on the cancer itself. This precise targeting could be a game changer, offering hope for better outcomes compared to existing therapies.

What evidence suggests that SGN-ALPV might be an effective treatment for solid tumor cancer?

Research shows that SGN-ALPV, the investigational treatment in this trial, may help treat solid tumors. This drug delivers a toxic substance called MMAE directly to cancer cells, causing them to die. Early lab studies, conducted before human testing, have shown promising results, suggesting it could work in people too. Although more research is needed to confirm these findings in humans, the initial results suggest that SGN-ALPV could be effective against hard-to-treat cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Suzanne McGoldrick, MD

Principal Investigator

Seagen Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors like stomach, cervical, testicular cancers and more. These tumors must be metastatic or unresectable. Participants need confirmed diagnoses and may require biopsies. They should not have had certain recent cancers or treatments that could interfere with the study.

Inclusion Criteria

This criterion means that individuals with ovarian cancer are included in the study.

It seems like the criterion is incomplete. Could you please provide more details or context so that I can assist you accurately?

You have endometrial cancer.

Exclusion Criteria

You have moderate or severe nerve damage before the study starts.

You have active cancer that has spread to your brain.

You have had another type of cancer in the past three years, or still have signs of a previous cancer, with some exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A and B)

Determine the appropriate dose of SGN-ALPV for participants

Approximately 6 months

Regular visits for dose adjustment and monitoring

Dose Expansion (Part C)

Evaluate the safety and efficacy of SGN-ALPV at the determined dose

Approximately 6 months

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days after last study treatment

What Are the Treatments Tested in This Trial?

Interventions

• SGN-ALPV

Trial Overview SGN-ALPV is being tested to determine its safety and effectiveness in treating various solid tumor cancers. The trial has three parts: Parts A and B will establish the proper dose; Part C will assess how safe it is at that dose and if it helps treat cancer.

How Is the Trial Designed?

Group I: SGN-ALPV Experimental Treatment 1 Intervention

SGN-ALPV 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

Published Research Related to This Trial

In a study of patients with brain metastases from ALK-rearranged non-small cell lung cancer, concurrent treatment with whole-brain radiotherapy (WBRT) and ALK tyrosine kinase inhibitors (TKIs) was linked to a higher incidence of severe ear toxicity, specifically grade 3 otitis media, compared to patients with other types of lung cancer.

The findings suggest that patients receiving this combination treatment may need closer monitoring for acute adverse events, particularly ear-related complications, as evidenced by a significant difference in otitis media cases between ALKr patients and those with EGFR mutations or wild-type NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Concurrent Radiotherapy and ALK Inhibitors for Brain Metastases of ALK-Rearranged Lung Adenocarcinoma. Nakashima, T., Nonoshita, T., Hirata, H., et al.[2023]

ALK tyrosine kinase inhibitors (TKIs) are associated with significantly higher cardiovascular toxicities compared to chemotherapy, with a risk ratio of 5.03, indicating a serious safety concern for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Among the ALK-TKIs, crizotinib specifically poses increased risks for cardiac disorders and venous thromboembolic events (VTEs), with risk ratios of 1.75 and 3.97, respectively, highlighting the need for careful monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of cardiovascular toxicities associated with ALK tyrosine kinase inhibitors in patients with non-small-cell lung cancer: a meta-analysis of randomized control trials. Zhao, J., Ma, Z., Li, H., et al.[2023]

Lorlatinib, a third-generation ALK tyrosine kinase inhibitor, demonstrates strong effectiveness in treating non-small cell lung cancer (NSCLC) patients with ALK mutations who have not responded to earlier treatments.

The safety profile of lorlatinib includes manageable side effects like hyperlipidemia and central nervous system issues, with few cases requiring permanent discontinuation, making it a well-tolerated option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in the Management of Adverse Events Associated with Lorlatinib. Liao, D., Zhang, J., Yan, T., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS3159

Phase 1 study of SGN-ALPV, a novel, investigational ... Promising preclinical data support the evaluation of SGN-ALPV in a clinical trial.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05229900

A Study of SGN-ALPV in Advanced Solid Tumors This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug.

3. pfizer.com pfizer.com/sites/default/files/plsr-studies/C5821001%28SGNALPV-001%29%20Plain%20Language%20Study%20Results%20Summary%20%28PLSRS%29%20Phase%201%20PK%20Primary%20Endpoint.pdf

Summary of the Results of the Clinical Trial for Laypersons Researchers think that SGN-ALPV will deliver the toxic agent called MMAE directly to cancer cells, causing the cells to die.

4. researchgate.net researchgate.net/publication/367697658_Phase_1_study_of_SGN-ALPV_a_novel_investigational_vedotin_antibody-drug_conjugate_directed_to_ALPPALPPL2_in_advanced_solid_tumors_SGNALPV-001_trial_in_progress

Phase 1 study of SGN-ALPV, a novel, investigational ... Five-year survival for newly diagnosed advanced ovarian cancer is less than 50%. ... efficacy data of different vaccine ... [Show full abstract] platforms. The ...

5. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-4-2022-b1545

SGN-ALPV for Cancer · Info for Participants Trial Overview SGN-ALPV is being tested to determine its safety and effectiveness in treating various solid tumor cancers. The trial has three parts: Parts A ...

6. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/1766/702188/Abstract-1766-SGN-ALPV-a-novel-investigational

Abstract 1766: SGN-ALPV a novel, investigational vedotin ... SGN-ALPV is a novel investigational vedotin ADC comprised of a humanized IgG1 monoclonal antibody conjugated to the microtubule disrupting agent ...

7. aacrjournals.org aacrjournals.org/mct/article/23/10/1483/748612/The-Vedotin-Antibody-Drug-Conjugate-Payload-Drives

The Vedotin Antibody–Drug Conjugate Payload Drives ... Vedotin ADC clinical safety profiles often share overlapping toxicities including bone marrow toxicity or neuropathy, which are generally considered antigen ...

8. ctv.veeva.com ctv.veeva.com/study/a-study-of-sgn-alpv-in-advanced-solid-tumors

A Study of SGN-ALPV in Advanced Solid Tumors This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this ...