Loading clinical trials...

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

NCT05571839•Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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
+5 more criteria

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

Locations (36)

UCLA Hematology/Oncology - Administrative Office

Los Angeles, California, United States

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate

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

UCLA Hematology/ Oncology- Pasadena

Pasadena, 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

UCLA Hematology/Oncology - Santa Barbara

Santa Barbara, California, United States

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)

Santa Monica, California, United States

Key Dates

Start Date

January 3, 2023

Primary Completion Date

June 6, 2026

Completion Date

June 6, 2026

Last Updated

March 13, 2026

Enrollment

41

ACTUAL participants

Conditions

Cutaneous MelanomaNon-small Cell Lung CancerColorectal NeoplasmsPancreatic NeoplasmsMesothelioma

Interventions

PF-08046049

DRUG

Sponsors

Lead Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Related Studies

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions