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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    210
  • sponsor
    Seagen Inc.
Updated on 19 September 2022
cancer
measurable disease
breast cancer
lung cancer
metastasis
progressive disease
pemetrexed
HER2
EGFR
biomarker analysis
pd-l1
adenocarcinoma
solid tumour
targeted therapy
erbb2
taxane
her2/neu-negative breast cancer
pdac
lung carcinoma
malignant melanoma of skin
metastatic cutaneous melanoma

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.

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.

Details
Condition Cutaneous Melanoma, Pleural Mesothelioma, HER2 Negative Breast Neoplasms, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Treatment SGN-CD228A
Clinical Study IdentifierNCT04042480
SponsorSeagen Inc.
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

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
Malignant pleural mesothelioma (MPM)
Advanced HER2-negative breast cancer
Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated
Advanced non-small cell lung cancer (NSCLC)
Advanced colorectal cancer
Participants must have received cisplatin and pemetrexed unless contraindicated
Advanced pancreatic ductal adenocarcinoma (PDAC)
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
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
Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate
Participants should be able to provide adequate tumor tissue for biomarker analysis
Participants must have unresectable or advanced PDAC
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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