A Study of SGN-CD228A in Advanced Solid Tumors

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04042480
Collaborator
(none)
210
14
1
60.9
15
0.2

Study Details

Study Description

Brief 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. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
Actual Study Start Date :
Sep 3, 2019
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SGN-CD228A

SGN-CD228A monotherapy

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with adverse events [Up to approximately 3.5 years]

    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.

  2. Number of participants with laboratory abnormalities [Up to approximately 3.5 years]

  3. Number of participants with dose limiting toxicities [Up to approximately 3.5 years]

Secondary Outcome Measures

  1. Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Up to approximately 3.5 years]

  2. Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only) [Up to approximately 3.5 years]

  3. Objective response rate (ORR) [Up to approximately 3.5 years]

    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.

  4. Progression-free survival (PFS) [Up to approximately 3.5 years]

    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.

  5. Overall survival (OS) [Up to approximately 3.5 years]

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

  6. Duration of objective response (DOR) [Up to approximately 3.5 years]

    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.

  7. Duration of complete response [Up to approximately 3.5 years]

    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.

  8. Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE) [Up to approximately 3.5 years]

  9. Cmax of free MMAE [Up to approximately 3.5 years]

  10. Cmax of total antibody [Up to approximately 3.5 years]

  11. Time to maximum concentration (Tmax) of acMMAE [Up to approximately 3.5 years]

  12. Tmax of free MMAE [Up to approximately 3.5 years]

  13. Tmax of total antibody [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 [Up to approximately 3.5 years]

  15. AUC(0-last) of free MMAE [Up to approximately 3.5 years]

  16. AUC(0-last) of total antibody [Up to approximately 3.5 years]

  17. Trough concentration (Ctrough) of acMMAE [Up to approximately 3.5 years]

  18. Ctrough of free MMAE [Up to approximately 3.5 years]

  19. Ctrough of total antibody [Up to approximately 3.5 years]

  20. Incidence of anti-drug antibodies (ADA) [Up to approximately 3.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

  • 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):

  • 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)

Exclusion Criteria

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35249
2 The Angeles Clinic and Research Institute Los Angeles California United States 90025
3 University of Chicago Medical Center Chicago Illinois United States 60637-1470
4 Wake Forest Baptist Medical Center / Wake Forest University Winston-Salem North Carolina United States 27157
5 Case Western Reserve University / University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
6 Oregon Health and Science University Portland Oregon United States 97239-3098
7 University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
8 Sanford Cancer Center Sioux Falls South Dakota United States 57104
9 MD Anderson Cancer Center / University of Texas Houston Texas United States 77030
10 South Texas Accelerated Research Therapeutics San Antonio Texas United States 78229
11 Institut Gustave Roussy Villejuif Cedex Other France 94805
12 Istituto Europeo di Oncologia Milano Other Italy 20141
13 Hospital Universitario Vall d'Hebron Barcelona Other Spain 08035
14 The Royal Marsden Hospital (Surrey) Sutton Other United Kingdom SM2 5PT

Sponsors and Collaborators

  • Seagen Inc.

Investigators

  • Study Director: Anu Gupta, MD, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seagen Inc.
ClinicalTrials.gov Identifier:
NCT04042480
Other Study ID Numbers:
  • SGN228-001
First Posted:
Aug 2, 2019
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seagen Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022