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Cutaneous MelanomaPhase 1NCT04042480

A Study of SGN-CD228A in Advanced Solid Tumors

A Phase 1 study testing SGN-CD228A in people with Cutaneous Melanoma and Pleural Mesothelioma, run by Seagen Inc. at 14 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SGN-CD228A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
14 sitesin 5 countries
Study dates
3 Sep 2019to 9 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available. Disease-specific escalation/expansion includes the following tumor types.
  • Metastatic cutaneous melanoma(MCM):
  • Metastatic or advanced cutaneous melanoma, excludes acral or mucosal varieties.
  • Participants must have received at least 1 PD-1-targeted therapy unless contraindicated.
  • Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.
  • Malignant pleural mesothelioma (MPM):
Show all 21Show fewer
  • Participants must have received cisplatin and pemetrexed unless contraindicated.
  • Advanced HER2-negative breast cancer:
  • Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane.
  • Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.
  • Advanced non-small cell lung cancer (NSCLC):
  • Participants must have locally advanced or metastatic EGFR wild-type NSCLC.
  • Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy as a single agent or as part of a combination unless contraindicated.
  • Advanced colorectal cancer:
  • Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.
  • Advanced pancreatic ductal adenocarcinoma (PDAC):
  • Participants must have unresectable or advanced PDAC.
  • Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.
  • Participants should be able to provide adequate tumor tissue for biomarker analysis
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Who cannot join

  • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
  • Pre-existing neuropathy Grade 2 or greater
  • Retinal or macular disease requiring treatment or ongoing active monitoring
  • Prior receipt of SGN-CD228A or MMAE-containing agents

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

United States10 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Case Western Reserve University / University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

  • Wake Forest Baptist Medical Center / Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

France1 site

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy1 site

  • Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

Spain1 site

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

United Kingdom1 site

  • The Royal Marsden Hospital (Surrey)

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors

This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

Read the detailed description

This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.

Being tested
SGN-CD228A
Keywords
HER2-negative breast cancer, Seattle Genetics
Medical subject headings
Melanoma, Mesothelioma, Malignant, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN-CD228ADrug

    SGN-CD228A administered into the vein (IV; intravenously)

Study groups in NCT04042480
Study groupRoleWhat they receive
SGN-CD228AExperimentalSGN-CD228A monotherapy
Receives: Drug: SGN-CD228A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    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.

    Measured: Up to approximately 3.5 years

  2. Number of participants with laboratory abnormalities

    Measured: Up to approximately 3.5 years

  3. Number of participants with dose limiting toxicities

    Measured: Up to approximately 3.5 years

Secondary outcomes (20)

  1. Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to approximately 3.5 years

  2. Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)

    Measured: Up to approximately 3.5 years

  3. Objective response rate (ORR)

    A participant is determined to have an OR if they achieve a complete response (CR) or partial response (PR) after initiation of study treatment and at or prior to the end-of-treatment disease assessment.

    Measured: Up to approximately 3.5 years

  4. Progression-free survival (PFS)

    Defined as the time from the start of study treatment to first documentation of disease progression or death due to any cause, whichever comes first.

    Measured: Up to approximately 3.5 years

  5. Overall survival (OS)

    Defined as the time from the start of any study treatment to the date of death due to any cause.

    Measured: Up to approximately 3.5 years

  6. Duration of objective response (DOR)

    Defined as the time from start of the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of confirm tumor progression or death due to any cause, whichever comes first.

    Measured: Up to approximately 3.5 years

  7. Duration of complete response

    Defined as the time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first.

    Measured: Up to approximately 3.5 years

  8. Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)

    Measured: Up to approximately 3.5 years

  9. Cmax of free MMAE

    Measured: Up to approximately 3.5 years

  10. Cmax of total antibody

    Measured: Up to approximately 3.5 years

  11. Time to maximum concentration (Tmax) of acMMAE

    Measured: Up to approximately 3.5 years

  12. Tmax of free MMAE

    Measured: Up to approximately 3.5 years

  13. Tmax of total antibody

    Measured: Up to approximately 3.5 years

  14. Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE

    Measured: Up to approximately 3.5 years

  15. AUC(0-last) of free MMAE

    Measured: Up to approximately 3.5 years

  16. AUC(0-last) of total antibody

    Measured: Up to approximately 3.5 years

  17. Trough concentration (Ctrough) of acMMAE

    Measured: Up to approximately 3.5 years

  18. Ctrough of free MMAE

    Measured: Up to approximately 3.5 years

  19. Ctrough of total antibody

    Measured: Up to approximately 3.5 years

  20. Incidence of anti-drug antibodies (ADA)

    Measured: Up to approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start3 Sep 2019
  3. Primary completion9 Mar 2023
  4. Study completion9 Mar 2023

Why it stopped: Study closed due to portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04042480
Sponsor's protocol ID
SGN228-001
Status last verified
Mar 2023
First submitted
31 Jul 2019
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mazahreh R, Mason ML, Gosink JJ, Olson DJ, Thurman R, Hale C, Westendorf L, Pires TA, Leiske CI, Carlson M, Nguyen LT, Cochran JH, Okeley NM, Yumul R, Jin S, Stone IJ, Sahetya D, Nesterova A, Allred S, Hensley KM, Hu R, Lawrence R, Lewis TS, Sandall S. SGN-CD228A Is an Investigational CD228-Directed Antibody-Drug Conjugate with Potent Antitumor Activity across a Wide Spectrum of Preclinical Solid Tumor Models. Mol Cancer Ther. 2023 Apr 3;22(4):421-434. doi: 10.1158/1535-7163.MCT-22-0401.

    PubMed 36800443

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SGN-CD228A in people with Cutaneous Melanoma and Pleural Mesothelioma, run by Seagen Inc. at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, France, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study closed due to portfolio prioritization). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Up to approximately 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04042480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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