A Study of SGN-EGFRd2 in Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983133
• Other study ID #: SGNEGFRd2-001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 14, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the safety of a drug called SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: September 30, 2028
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tumor types:
• For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor

types:

• Colorectal cancer (CRC)
• Non-small cell lung cancer (NSCLC)
• Head and neck squamous cell cancer (HNSCC)
• For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.
• The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.
• For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless

contraindicated:

• CRC
• Participants must have unresectable locally advanced or metastatic CRC.
• Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.
• NSCLC
• Participants must have unresectable locally advanced or metastatic NSCLC.
• Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase [ALK], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.
• HNSCC
• Participants must have unresectable locally advanced or metastatic HNSCC
• Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.
• Pancreatic ductal adenocarcinoma (PDAC)
• Participants must have unresectable locally advanced or metastatic PDAC.
• Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.
• Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Measurable disease at baseline per RECIST 1.1 criteria.

Exclusion Criteria:

• History of another malignancy within 3 years before the first dose of study treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
• Known active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are
• clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
• they have no new or enlarging brain metastases,
• and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
• Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
• Participants with history of thromboembolic phenomena (pulmonary embolism, deep vein thrombosis, stroke, or ischemic attack) within 6 months prior to the first dose of study drug, currently receiving chronic anticoagulation therapy, or with contraindication to treatment for thromboembolism prophylaxis.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Pancreatic Ductal Adenocarcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• SGN-EGFRd2
Given into the vein (IV; intravenously)

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Providence Portland Medical Center	Portland	Oregon
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	UCLA Department of Medicine - Hematology & Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention	Through 90 days after last study treatment, up to approximately 1 year
Primary	Number of participants with laboratory abnormalities		Through 30-37 days after last study treatment, up to approximately 1 year
Primary	Number of participants with dose limiting toxicities (DLTs)		Up to 35 days
Primary	Number of participants with DLTs by dose level		Up to 35 days
Secondary	Number of participants with antidrug antibodies (ADAs)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	Pharmacokinetic (PK) parameter - Area under the curve (AUC)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	PK parameter - Maximum concentration (Cmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	PK parameter - Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, up to approximately 1 year
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.	Up to approximately 2 years
Secondary	Duration of response (DOR)	DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first	Up to approximately 2 years
Secondary	Progression-free survival (PFS)	PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first	Up to approximately 2 years
Secondary	Overall survival (OS)	OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause	Up to approximately 3 years