A Study of SGN-ALPV in Advanced Solid Tumors

February 6, 2025 updated by: Seagen Inc.

A Phase 1 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. 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital
  • Spain
    • Other
      • Madrid, Other, Spain, 28050
        • START Madrid-CIOCC_Hospital HM Sanchinarro
  • Sweden
    • Other
      • Stockholm, Other, Sweden, 171 76
        • Karolinska University Hospital
  • United Kingdom
    • Other
      • London, Other, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, Other, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust (RM)
  • United States
    • California
      • Fresno, California, United States, 93710
        • Women'S Cancer Care
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cancer Center
    • Florida
      • Wellington, Florida, United States, 33414
        • Florida Cancer Specialists - Lake Nona
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • START Midwest
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University at Stephenson Cancer Center
    • Utah
      • West Valley City, Utah, United States, 84119
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGN-ALPV
SGN-ALPV monotherapy
Drug: SGN-ALPV
Given into the vein (IV; intravenously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Through 30-37 days after last study treatment, approximately 6 months
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
Time Frame: Through 30-37 days after last study treatment, approximately 6 months
Through 30-37 days after last study treatment, approximately 6 months
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with DLTs by dose level
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of antidrug antibodies (ADAs)
Time Frame: Through 30-37 days after last study treatment, approximately 6 months
Through 30-37 days after last study treatment, approximately 6 months
Area under the concentration-time curve (AUC)
Time Frame: Through 14 days after last study treatment, approximately 6 months
PK parameter
Through 14 days after last study treatment, approximately 6 months
Maximum concentration (Cmax)
Time Frame: Through 14 days after last study treatment, approximately 6 months
PK parameter
Through 14 days after last study treatment, approximately 6 months
Time to Cmax (Tmax)
Time Frame: Through 14 days after last study treatment, approximately 6 months
PK parameter
Through 14 days after last study treatment, approximately 6 months
Apparent terminal half-life (t1/2)
Time Frame: Through 14 days after last study treatment, approximately 6 months
PK parameter
Through 14 days after last study treatment, approximately 6 months
Trough concentration (Ctrough)
Time Frame: Through 14 days after last study treatment, approximately 6 months
PK parameter
Through 14 days after last study treatment, approximately 6 months
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: Approximately 2 years
The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.
Approximately 2 years
Duration of objective response (DOR)
Time Frame: Approximately 2 years
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.
Approximately 2 years
Progression-free survival (PFS)
Time Frame: Approximately 2 years
The time from start of study treatment to first documentation of disease progression or death due to any cause
Approximately 2 years
Overall survival (OS)
Time Frame: Approximately 2 years
The time from start of study treatment to death due to any cause
Approximately 2 years
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
Time Frame: Approximately 2 years
The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria
Approximately 2 years
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
Time Frame: Approximately 2 years
The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Suzanne McGoldrick, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

December 13, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNALPV-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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