The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Clinical Trial Details
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Melanoma
Other or Multiple Cancer Types
CD228-directed Antibody-Anticalin® Bispecific Protein
PF-08046049, SGN-BB228 is an investigational compound. Its safety and efficacy have not been established
A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Phase 1
NCT05571839
Active enrolling
Locations
United States, Canada, France, Germany, Switzerland, United Kingdom
Study design
Participant Group/Arm
EXPERIMENTAL: SGN-BB228
SGN-BB228 monotherapy
Intervention/Treatment
DRUG: SGN-BB228
Given into the vein (IV; intravenous)
Key eligibility criteria
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 entr
- 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
Key dates
Study start date
- January 2023
Estimated primary completion date
- September 2028
Key endpoints
Primary Outcome Measures
Outcome Measure
Number of participants with adverse events (AEs)
Measure Description
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.
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
Number of participants with laboratory abnormalities
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
Number of participants with dose limiting toxicities
Time Frame
Up to 28 days
Secondary Outcome Measures:
Outcome Measure
Number of participants with antidrug antibodies
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
PK parameter - Maximum Concentration (Cmax)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
PK parameter - Time to maximum concentration (Tmax)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
PK parameter - Apparent terminal half-life (t1/2)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
PK parameter - Trough concentration (Ctrough)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Outcome Measure
Objective response rate (ORR)
Measure Description
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
Time Frame
Up to approximately 1 year
Outcome Measure
Duration of response (DOR)
Measure Description
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
Time Frame
Up to approximately 1 year
Outcome Measure
Progression-free survival (PFS)
Measure Description
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
Time Frame
Up to approximately 1 year
Outcome Measure
Overall survival (OS)
Measure Description
The time from the start of study treatment to death due to any cause
Time Frame
Approximately 2 years
Number of participants
275
Collaborators and investigators
Sponsor: Seagen Inc.
Collaborator: None