A Study of SGN-ALPV in Advanced Solid Tumors

NCT05229900 | Terminated Phase 1 FDA Drug

• 1 other identifier: SGNALPV-001
• Study Type: interventional
• Target: 43
• Locations: 5 countries
• Sites: 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

Keywords

Ovarian cancer; Endometrial cancer; Non-small cell lung cancer; NSCLC; Gastric cancer; GEJ carcinoma; Cervical cancer; Malignant Testicular Germ Cell Tumor; Malignant Ovarian Germ Cell Tumor; Malignant Extragonadal Germ Cell Tumor; High-grade serous ovarian cancer; HGSOC; Seattle Genetics

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs)

  Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  Through 30-37 days after last study treatment, approximately 6 months

• Number of participants with laboratory abnormalities

  Through 30-37 days after last study treatment, approximately 6 months

• Number of participants with dose-limiting toxicities (DLTs)

  Up to 28 days

• Number of participants with DLTs by dose level

  Up to 28 days

Secondary Outcomes (12)

• Incidence of antidrug antibodies (ADAs)

  Through 30-37 days after last study treatment, approximately 6 months

• Area under the concentration-time curve (AUC)

  Through 14 days after last study treatment, approximately 6 months

• Maximum concentration (Cmax)

  Through 14 days after last study treatment, approximately 6 months

• Time to Cmax (Tmax)

  Through 14 days after last study treatment, approximately 6 months

• Apparent terminal half-life (t1/2)

  Through 14 days after last study treatment, approximately 6 months

Study Arms (1)

SGN-ALPV

EXPERIMENTAL

SGN-ALPV monotherapy

Drug: SGN-ALPV

Interventions

SGN-ALPV DRUG

Given into the vein (IV; intravenously)

SGN-ALPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (13)

Women's Cancer Care

Fresno, California, 93710, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Florida Cancer Specialists - Lake Nona

Wellington, Florida, 33414, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Oklahoma University at Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

START Mountain Region

West Valley City, Utah, 84119, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

START Madrid-CIOCC_Hospital HM Sanchinarro

Madrid, Other, 28050, Spain

Location

Karolinska University Hospital

Stockholm, Other, 171 76, Sweden

Location

The Royal Marsden NHS Foundation Trust (RM)

London, Other, SW3 6JJ, United Kingdom

Location

Sarah Cannon Research Institute UK

London, Other, W1G 6AD, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Uterine Cervical Neoplasms; Testicular Neoplasms; Ovarian Germ Cell Cancer

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Cervical Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Study Officials

• Suzanne McGoldrick, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 8, 2022
• Study Start: April 21, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

ES (1); CA (2); SE (1); US (7); GB (2)