A Study Of PF-08046049/SGN-BB228 In Advanced Melanoma And Other Solid Tumors

Study Overview

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This study will test the safety of a drug called PF-08046049/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 PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.

N/A

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

DRUG: PF-08046049

SGNBB228-001
C5871001 (OTHER Identifier) (OTHER: Alias Study Number)
2022-502348-11-00 (REGISTRY Identifier) (REGISTRY: CTIS (EU))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-11
First Submitted that Met QC Criteria 2022-10-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-17
First Posted (ESTIMATED) 2022-10-07	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PF-08046049 PF-08046049 monotherapy	DRUG: PF-08046049 Given into the vein (IV; intravenous)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PF-08046049

PF-08046049 monotherapy

DRUG: PF-08046049

Given into the vein (IV; intravenous)

Primary Outcome Measures	Measure Description	Time Frame
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
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	Measure Description	Time Frame
Number of participants with antidrug antibodies	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
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
PK parameter - Maximum Concentration (Cmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
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
PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30 days after the last study treatment; approximately 7 months
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
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
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
Overall survival (OS)	The time from the start of study treatment to death due to any cause	Approximately 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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
Melanoma subtypes including acral, uveal, and mucosal are excluded

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record