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

Phase 1

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer; Pancreatic Neoplasms; Mesothelioma; Cutaneous Melanoma; Colorectal Neoplasms
• Interventions: Drug: PF-08046049

• Registration Number: NCT05571839
• Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Study Start: 2023-01-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-09-17
• Study Completion: 2025-10-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PF-08046049	PF-08046049	PF-08046049 monotherapy

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities	Up to 28 days
Number of participants with laboratory abnormalities	Through 30 days after the last study treatment; approximately 7 months
Number of participants with adverse events (AEs)	Through 30 days after the last study treatment; approximately 7 months	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to approximately 1 year	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
Pharmacokinetic (PK) parameter - Area under the curve (AUC)	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics
Number of participants with antidrug antibodies	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics
Duration of response (DOR)	Up to approximately 1 year	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
PK parameter - Time to maximum concentration (Tmax)	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics
PK parameter - Apparent terminal half-life (t1/2)	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics
PK parameter - Trough concentration (Ctrough)	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics
Overall survival (OS)	Approximately 2 years	The time from the start of study treatment to death due to any cause
Progression-free survival (PFS)	Up to approximately 1 year	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
PK parameter - Maximum Concentration (Cmax)	Through 30 days after the last study treatment; approximately 7 months	To be summarized using descriptive statistics

Trial Locations

Locations (32)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Building - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Rochester.; 🇺🇸 Rochester, Minnesota, United States

Institut Gustave Roussy; 🇫🇷 Villejuif Cedex, France

UCLA Hematology/Oncology - Administrative Office; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Ronald Reagan UCLA Medical Center, Drug Information Center; 🇺🇸 Los Angeles, California, United States

UCLA Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

UCSF Medical Center, Investigational Pharmacy; 🇺🇸 San Francisco, California, United States

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