A Study of SGN-BB228 to Treat Advanced Melanoma and Other Solid Tumors

Overview

About this study

The purpose of this study is to test the safety and side effects 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. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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

- 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 declined 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.

- 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/9/23. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert McWilliams, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Ruqin Chen, M.D., M.B.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available