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

Overview

Información sobre este estudio

The purpose of this study is to test the safety and side effects of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Yiyi Yan, M.D., Ph.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Investigador principal de Mayo Clinic

Robert McWilliams, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mahesh Seetharam, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

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