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

Geo Regions

Category

Melanoma

Category

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 PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Phase 1
NCT05571839

Active enrolling

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Locations

United States, Canada, France, Germany, Switzerland, United Kingdom

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Study design

Participant Group/Arm

EXPERIMENTAL: PF-08046049

PF-08046049 monotherapy

Intervention/Treatment

DRUG: PF-08046049

Given into the vein (IV; intravenous)

Study design table for Clinical Trial

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:
  • 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 dru
  • 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

Key dates

Study start date
  • January 2023
Estimated primary completion date
  • November 2027

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

Measure Description

Time Frame

Through 30 days after the last study treatment; approximately 7 months

Outcome Measure

Number of participants with dose limiting toxicities

Measure Description

Time Frame

Up to 28 days

Primary Outcome Measures table for Clinical Trial
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

Secondary Outcome Measures table for Clinical Trial

Number of participants

275

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of October 1st 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT05571839