Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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