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

Sponsor

Seagen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05571839

Collaborator

(none)

275

Enrollment

Location

Arm

68.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Melanoma Non-small Cell Lung Cancer Colorectal Neoplasms Pancreatic Neoplasms Mesothelioma	Drug: SGN-BB228	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

275 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Sep 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-BB228 SGN-BB228 monotherapy	Drug: SGN-BB228 Given into the vein (IV; intravenous)

Arm

Intervention/Treatment

Experimental: SGN-BB228

SGN-BB228 monotherapy

Drug: SGN-BB228

Given into the vein (IV; intravenous)

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events (AEs) [Through 30 days after the last study treatment; approximately 7 months]
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.
Number of participants with laboratory abnormalities [Through 30 days after the last study treatment; approximately 7 months]
Number of participants with dose limiting toxicities [Up to 28 days]

Secondary Outcome Measures

Number of participants with antidrug antibodies [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
Pharmacokinetic (PK) parameter - Area under the curve (AUC) [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
PK parameter - Maximum Concentration (Cmax) [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
PK parameter - Time to maximum concentration (Tmax) [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
PK parameter - Apparent terminal half-life (t1/2) [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
PK parameter - Trough concentration (Ctrough) [Through 30 days after the last study treatment; approximately 7 months]
To be summarized using descriptive statistics
Objective response rate (ORR) [Up to approximately 1 year]
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
Duration of response (DOR) [Up to approximately 1 year]
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
Progression-free survival (PFS) [Up to approximately 1 year]
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
Overall survival (OS) [Approximately 2 years]
The time from the start of study treatment to death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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
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 declined 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.
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