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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05571839




Registration number
NCT05571839
Ethics application status
Date submitted
5/10/2022
Date registered
7/10/2022

Titles & IDs
Public title
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Scientific title
A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Secondary ID [1] 0 0
C5871001
Secondary ID [2] 0 0
SGNBB228-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma 0 0
Non-small Cell Lung Cancer 0 0
Colorectal Neoplasms 0 0
Pancreatic Neoplasms 0 0
Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-08046049

Experimental: PF-08046049 - PF-08046049 monotherapy


Treatment: Drugs: PF-08046049
Given into the vein (IV; intravenous)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Through 30 days after the last study treatment; approximately 7 months
Primary outcome [2] 0 0
Number of participants with laboratory abnormalities
Timepoint [2] 0 0
Through 30 days after the last study treatment; approximately 7 months
Primary outcome [3] 0 0
Number of participants with dose limiting toxicities
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Number of participants with antidrug antibodies
Timepoint [1] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [2] 0 0
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Timepoint [2] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [3] 0 0
PK parameter - Maximum Concentration (Cmax)
Timepoint [3] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [4] 0 0
PK parameter - Time to maximum concentration (Tmax)
Timepoint [4] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [5] 0 0
PK parameter - Apparent terminal half-life (t1/2)
Timepoint [5] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [6] 0 0
PK parameter - Trough concentration (Ctrough)
Timepoint [6] 0 0
Through 30 days after the last study treatment; approximately 7 months
Secondary outcome [7] 0 0
Objective response rate (ORR)
Timepoint [7] 0 0
Up to approximately 1 year
Secondary outcome [8] 0 0
Duration of response (DOR)
Timepoint [8] 0 0
Up to approximately 1 year
Secondary outcome [9] 0 0
Progression-free survival (PFS)
Timepoint [9] 0 0
Up to approximately 1 year
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
Approximately 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/11/2027
Actual
Sample size
Target
275
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Other
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Other
Country [17] 0 0
Germany
State/province [17] 0 0
Other
Country [18] 0 0
Switzerland
State/province [18] 0 0
Other
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Other

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
clinicaltrials@seagen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05571839