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

Part of paid clinical trials in Miami, Florida.

Sponsor
Syntrix Biosystems, Inc.
Study ID
NCT03161431
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SX-682 — DRUG
    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)
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab is a humanized antibody that targets the programmed cell death 1 receptor (PD-1).

Study Details

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.

Key Dates

First listed
May 19, 2017
Start date
Jun 12, 2019
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy: SX-682 dose escalation
    Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.
  • Experimental: Combination therapy: SX-682 dose escalation with pembrolizumab
    SX-682 will be administrated at the same dose the participant was administered in monotherapy and will be administered in a 6 week cycle that includes 2 i.v. infusions of pembrolizumab on days 1 and 22 of each cycle, for a total of up to 17 cycles. Once the highest safe dose of SX-682 in combination therapy with pembrolizumab is determined, participants will be enrolled in an expansion phase at that SX-682 dose with pembrolizumab combination therapy.

Primary Outcome Measure

SX-682 Maximum Tolerated Dose (MTD) during Monotherapy Stage [ Time Frame: Up to 21 Days in 21 day Cycle 1 of Monotherapy Stage. ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-
Wilmot Cancer Institute - University of RochesterRochesterNew York14642-
MD AndersonHoustonTexas77030-

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MAMayo Clinic· Rochester, MNWilmot Cancer Institute - University of Rochester· Rochester, NYMD Anderson· Houston, TX

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