Ovarian Cancer Clinical Trial

A Study of SGN-ALPV in Advanced Solid Tumors

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.

View Eligibility Criteria

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
Cervical cancer
Malignant testicular germ cell tumor (GCT), except for pure teratomas
Malignant ovarian GCT, except for pure teratomas

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: Participants must have unresectable locally advanced or metastatic gastric cancer 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

Disease-specific expansion cohorts, subjects 16 onwards: pretreatment biopsy.
Biology expansion cohort: pretreatment biopsy, on-treatment biopsy during Cycle 1, and end of treatment biopsy.
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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

285

Study ID:

NCT05229900

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 10 Locations for this study

See Locations Near You

Women's Cancer Care
Fresno California, 93710, United States More Info
Micheal Mott
Contact
559-650-4880
[email protected]
Christopher Perkins
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Yale Cancer Center Ct.Gov Contact
Contact
[email protected]
Patricia LoRusso
Principal Investigator
Florida Cancer Specialists - Lake Nona
Wellington Florida, 33414, United States More Info
Leslie Hertweck
Contact
[email protected]
Cesar Perez Batista, MD
Principal Investigator
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Julie Burns
Contact
616-954-5559
[email protected]
Nehal Lakhani, MD, PhD
Principal Investigator
Oklahoma University at Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Julia Neuenschwander
Contact
405-271-8001
[email protected]
Kathleen Moore
Principal Investigator
START Mountain Region
West Valley City Utah, 84119, United States More Info
Kellie Breen
Contact
210-593-5259
[email protected]
Justin Call
Principal Investigator
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Maryanne Poole
Contact
703-280-5390
[email protected]
Alexander I Spira
Principal Investigator
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid Other, 28050, Spain More Info
Maria Jose de Miguel
Principal Investigator
The Royal Marsden NHS Foundation Trust (RM)
London Other, SW3 6, United Kingdom More Info
Anna Minchom
Principal Investigator
Sarah Cannon Research Institute UK
London Other, W1G 6, United Kingdom More Info
Elisa Fontana
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

285

Study ID:

NCT05229900

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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