A Study of SGN-CD228A in Advanced Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04042480
• Other study ID #: SGN228-001
• Status: Terminated
• Phase: Phase 1
• Start date: September 3, 2019
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif Cedex
Italy	Istituto Europeo di Oncologia	Milano
Spain	Hospital Universitario Vall d'Hebron	Barcelona
United Kingdom	The Royal Marsden Hospital (Surrey)	Sutton
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Case Western Reserve University / University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	Sanford Cancer Center	Sioux Falls	South Dakota
United States	Wake Forest Baptist Medical Center / Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	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.	Up to approximately 3.5 years
Primary	Number of participants with laboratory abnormalities		Up to approximately 3.5 years
Primary	Number of participants with dose limiting toxicities		Up to approximately 3.5 years
Secondary	Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		Up to approximately 3.5 years
Secondary	Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)		Up to approximately 3.5 years
Secondary	Objective response rate (ORR)	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.	Up to approximately 3.5 years
Secondary	Progression-free survival (PFS)	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.	Up to approximately 3.5 years
Secondary	Overall survival (OS)	Defined as the time from the start of any study treatment to the date of death due to any cause.	Up to approximately 3.5 years
Secondary	Duration of objective response (DOR)	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.	Up to approximately 3.5 years
Secondary	Duration of complete response	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.	Up to approximately 3.5 years
Secondary	Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)		Up to approximately 3.5 years
Secondary	Cmax of free MMAE		Up to approximately 3.5 years
Secondary	Cmax of total antibody		Up to approximately 3.5 years
Secondary	Time to maximum concentration (Tmax) of acMMAE		Up to approximately 3.5 years
Secondary	Tmax of free MMAE		Up to approximately 3.5 years
Secondary	Tmax of total antibody		Up to approximately 3.5 years
Secondary	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
Secondary	AUC(0-last) of free MMAE		Up to approximately 3.5 years
Secondary	AUC(0-last) of total antibody		Up to approximately 3.5 years
Secondary	Trough concentration (Ctrough) of acMMAE		Up to approximately 3.5 years
Secondary	Ctrough of free MMAE		Up to approximately 3.5 years
Secondary	Ctrough of total antibody		Up to approximately 3.5 years
Secondary	Incidence of anti-drug antibodies (ADA)		Up to approximately 3.5 years