A Study of SGN-CD228A in Advanced Solid Tumors

STATUS

Recruiting
End date

Sep 30, 2024
participants needed

210
sponsor

Seagen Inc.

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Updated on 1 July 2022

See if I qualify

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 Identifier	NCT04042480
Sponsor	Seagen Inc.
Last Modified on	1 July 2022

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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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Step 4 Get your study results

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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A Study of SGN-CD228A in Advanced Solid Tumors