SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab

Summary

Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune responses from destroying the cancer. This study will be the first study to begin to determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This first study will enroll participants with melanoma, as melanoma cancer has been shown to be able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer, and thus will allow a patient's own immune system to attack the cancer.

The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy. After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for melanoma) in combination with SX-682 for up to approximately 2 years.

Once the safe dose level of SX-682 in combination with pembrolizumab is determined, the remaining participants will be enrolled at the highest safe dose level of SX-682, in combination with pembrolizumab. These participants will receive the combination therapy and be evaluated in the study for approximately 2 years.

Conditions

• Melanoma Stage III
• Melanoma Stage IV

Interventions

DRUG

SX-682

SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and C-X-C Motif Chemokine Receptor 2 (CXCR2)

BIOLOGICAL

Pembrolizumab

Pembrolizumab is a humanized antibody that targets the programmed cell death 1 receptor (PD-1).

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Dana-Farber Cancer Institute

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Syntrix Biosystems, Inc.

  lead INDUSTRY

Principal Investigators

• Stuart Kahn, M.D. · Syntrix Biosystems

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-12

Primary Completion

2026-08-31

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States

Study Locations