SGN-ALPV for Cancer

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

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SGN-ALPV in patients with advanced solid tumors. It aims to find the right dosage and see if the drug is safe and effective.

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.

What safety information is available for SGN-ALPV or similar treatments?

The safety of ALK inhibitors, which may be similar to SGN-ALPV, has been studied in patients with lung cancer. These treatments are generally well-tolerated, but they can cause side effects like heart issues, digestive problems, and changes in mood or behavior. It's important to monitor these side effects and manage them with medical guidance. ^{1 2 3 4 5}

Research Team

Suzanne McGoldrick, MD

Principal Investigator

Seagen Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events of Concurrent Radiotherapy and ALK Inhibitors for Brain Metastases of ALK-Rearranged Lung Adenocarcinoma. [2023]

2. England 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. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Psychiatric Adverse Reactions to Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer: Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System. [2022]

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

Recent Advances in the Management of Adverse Events Associated with Lorlatinib. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Safety of alectinib for the treatment of metastatic ALK-rearranged non-small cell lung cancer. [2019]