Clinical trial NCT05571839: A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Official title: A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cutaneous Melanoma
Non-small Cell Lung Cancer
Colorectal Neoplasms
Pancreatic Neoplasms
Mesothelioma
Keywords: NSCLC
Colorectal Cancer
CRC
Pancreatic Cancer
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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 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
* Melanoma subtypes including acral, uveal, and mucosal are excluded

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: Number of participants with dose limiting toxicities
timeFrame: Up to 28 days
Secondary outcomes:
measure: Number of participants with antidrug antibodies
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: Pharmacokinetic (PK) parameter - Area under the curve (AUC)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: PK parameter - Maximum Concentration (Cmax)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: PK parameter - Time to maximum concentration (Tmax)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: PK parameter - Apparent terminal half-life (t1/2)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: PK parameter - Trough concentration (Ctrough)
timeFrame: Through 30 days after the last study treatment; approximately 7 months
measure: Objective response rate (ORR)
timeFrame: Up to approximately 1 year
measure: Duration of response (DOR)
timeFrame: Up to approximately 1 year
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 1 year
measure: Overall survival (OS)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Administrative Office
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Drug Information Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center, Investigational Pharmacy
state: California
city: Santa Monica
country: United States
facility: The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)
state: California
city: Denver
country: United States
facility: Quest Diagnostics Incorporated - Denver
state: Colorado
city: Denver
country: United States
facility: Presbyterian St. Lukes Medical Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian/St. Lukes Medical Center
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE - Denver
state: Colorado
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital Clinic Lab (285)
state: Massachusetts
city: Boston
country: United States
facility: BWH
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Raritan
country: United States
facility: Laboratory Corporation of America
state: New Jersey
city: New York
country: United States
facility: New York University (NYU) Cancer Institute
state: New York
city: New York
country: United States
facility: NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center(Tisch Hospital)
state: New York
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Sammons Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa / Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Villejuif
country: France
facility: Insitut Gustave Roussy
state: Cedex
city: Villejuif Cedex
country: France
facility: Insitut Gustave Roussy
city: Berlin
country: Germany
facility: Clinical Research Center Dermatology (CRCD) Dermatoonkologie Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich Dermatologische Klinik
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: