A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571839
• Other study ID #: SGNBB228-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 3, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: June 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-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. 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.

This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe 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: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.

• Participants must have one of the following tumor types:

• Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma.

• Part C: Participants must have one of the following tumor types:

• Cutaneous Melanoma

• Non-small Cell Lung Cancer (NSCLC)

• Colorectal Cancer (CRC)

• Pancreatic Cancer

• Mesothelioma

• A pre-treatment biopsy or submission of archival tissue is required

• For participants with cutaneous melanoma

• Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.

• Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry.

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

• Measurable disease per 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.

• 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 metastasis 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.

• Prior therapies cannot include any drugs targeting CD228 or 4-1BB

• Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Cutaneous Melanoma
• Melanoma
• Mesothelioma
• Neoplasms
• Non-small Cell Lung Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• SGN-BB228
Given into the vein (IV; intravenous)

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	University Health Network, Princess Margaret Hospital	Toronto	Other
France	Institut Gustave Roussy	Villejuif Cedex	Other
Germany	Charite Universitatsmedizin Berlin	Berlin	Other
Switzerland	Universitatsspital Zurich	Zurich	Other
United Kingdom	NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre	Glasgow	Other
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Texas Oncology - Baylor Sammons Cancer Center	Dallas	Texas
United States	Sarah Cannon Research Institute at HealthONE - Denver	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	NYU Langone Hospital	New York	New York
United States	University of California, San Francisco | HDFCCC - Hematopoietic Malignancies	San Francisco	California
United States	Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	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.	Through 30 days after the last study treatment; approximately 7 months
Primary	Number of participants with laboratory abnormalities		Through 30 days after the last study treatment; approximately 7 months
Primary	Number of participants with dose limiting toxicities		Up to 28 days
Secondary	Number of participants with antidrug antibodies	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	Pharmacokinetic (PK) parameter - Area under the curve (AUC)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	PK parameter - Maximum Concentration (Cmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	PK parameter - Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
Secondary	Objective response rate (ORR)	The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator	Up to approximately 1 year
Secondary	Duration of response (DOR)	The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause	Up to approximately 1 year
Secondary	Progression-free survival (PFS)	The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause	Up to approximately 1 year
Secondary	Overall survival (OS)	The time from the start of study treatment to death due to any cause	Approximately 2 years