A Study of SGN-ALPV in Advanced Solid Tumors

NCT ID: NCT05229900

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2023-12-13

Brief Summary

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. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Gastroesophageal Junction Carcinoma; Uterine Cervical Neoplasms; Testicular Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGN-ALPV

SGN-ALPV monotherapy

Group Type: EXPERIMENTAL

SGN-ALPV

Intervention Type: DRUG

Given into the vein (IV; intravenously)

Interventions

SGN-ALPV

Given into the vein (IV; intravenously)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:

• Parts A and B

• Ovarian cancer
• Endometrial cancer
• Non-small cell lung cancer (NSCLC)
• Gastric cancer, including gastroesophageal junction (GEJ) carcinoma
• Cervical cancer
• Malignant testicular germ cell tumor (GCT), except for pure teratomas
• Malignant ovarian GCT, except for pure teratomas
• Malignant extragonadal GCT except for pure teratomas or tumors with primaries arising from CNS
• Part C

• High-grade serous ovarian cancer (HGSOC): Participants must have HGSOC which has progressed or relapsed within 6 months after previous platinum containing chemotherapy, received 2 to 4 prior anticancer lines of therapy, and at least 1 line of therapy in the platinum-resistant setting. If eligible at least 1 line of therapy must have contained bevacizumab or a biosimilar to bevacizumab.
• Endometrial Cancer: Participants must have unresectable locally advance or metastatic endometrial carcinoma and have had at least 1 prior line of therapy.
• NSCLC: Participants must have unresectable locally advanced or metastatic NSCLC and have received platinum-based therapy and a PD-(L)1 inhibitor.
• Gastric cancer or GEJ carcinoma: Participants must have unresectable locally advanced or metastatic gastric cancer or GEJ carcinoma and have received prior platinum and fluoropyrimidine -based chemotherapy
• Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy

• Part B dose and schedule optimization cohorts and Part C disease-specific expansion cohorts: pretreatment biopsy, unless clinically infeasible following consultation with the medical monitor.
• Part C biology expansion cohort: pretreatment biopsy (required), on-treatment biopsy during Cycle 1 (unless clinically infeasible following consultation with the medical monitor)
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Measurable disease per the RECIST v1.1 at baseline

Exclusion Criteria

• History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
• Known active central nervous system metastases.
• Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
• Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne McGoldrick, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

Women's Cancer Care

Fresno, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists - Lake Nona

Wellington, Florida, United States

START Midwest

Grand Rapids, Michigan, United States

Oklahoma University at Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

START Mountain Region

West Valley City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

START Madrid-CIOCC_Hospital HM Sanchinarro

Madrid, Other, Spain

Karolinska University Hospital

Stockholm, Other, Sweden

The Royal Marsden NHS Foundation Trust (RM)

London, Other, United Kingdom

Sarah Cannon Research Institute UK

London, Other, United Kingdom

Countries

United States; Canada; Spain; Sweden; United Kingdom

Other Identifiers

SGNALPV-001

Identifier Type: -

Identifier Source: org_study_id