Clinical Trials /

A Study of SGN-CD228A in Advanced Solid Tumors

NCT04042480

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Cutaneous Melanoma
  • Malignant Pleural Mesothelioma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of SGN-CD228A in Advanced Solid Tumors
  • Official Title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SGN228-001
  • NCT ID: NCT04042480

Conditions

  • Cutaneous Melanoma
  • Pleural Mesothelioma
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma

Interventions

DrugSynonymsArms
SGN-CD228ASGN-CD228A

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
SGN-CD228AExperimental
  • SGN-CD228A

Eligibility Criteria

        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.

          -  Dose escalation

               -  Advanced cutaneous melanoma

               -  Malignant pleural mesothelioma (MPM)

               -  Advanced HER2-negative breast cancer

               -  Advanced non-small cell lung cancer (NSCLC)

               -  Advanced colorectal cancer

               -  Advanced pancreatic ductal adenocarcinoma (PDAC)

          -  Disease-specific dose expansion

               -  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.

               -  MPM: Participants must have received cisplatin and pemetrexed unless
                  contraindicated.

               -  Advanced HER2- 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 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 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.

               -  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) at baseline

        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 SGN228A or MMAE-containing agents
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with adverse events
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best response per RECIST
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Best response per mRECIST
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Objective response (OR) rate
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description: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.
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description: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.
Measure:Overall survival (OS)
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:Defined as the time from the start of any study treatment to the date of death due to any cause.
Measure:Duration of objective response (DOR)
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of confirm tumor progression or death due to any cause, whichever comes first.
Measure:Duration of complete response
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description: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.
Measure:Maximum concentration (Cmax) of acMMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Cmax of free MMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Cmax of total antibody
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Time to maximum concentration (Tmax) of acMMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Tmax of free MMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Tmax of total antibody
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve from time 0 to the last available
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:AUC(0-last) of free MMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:AUC(0-last) of total antibody
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Trough concentration (Ctrough) of acMMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Ctrough of free MMAE
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Ctrough of total antibody
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:
Measure:Incidence of antitherapeutic antibodies (ATA)
Time Frame:Up to approximately 3.5 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • HER2-negative breast cancer

Last Updated