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.
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
Drug | Synonyms | Arms |
---|
SGN-CD228A | | SGN-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
Name | Type | Description | Interventions |
---|
SGN-CD228A | Experimental | SGN-CD228A administered intravenously | |
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 (participants with pleural mesothelioma only) |
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: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- HER2-negative breast cancer
- Seattle Genetics
Last Updated
June 1, 2021