A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed abiraterone.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.

• Diagnosis of mCRPC with (a) any histology and (b) currently on or previously on abiraterone/prednisone (or abiraterone/dexamethasone) with documented progression in either the mCRPC or mHSPC settings, and with:

‣ rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng/mL by local testing); or

⁃ progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan; no abiraterone washout necessary.

• Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future pathologic review and possible correlative studies.

• Castrate levels of serum total testosterone (\<50 ng/dl) OR ongoing documented ADT.

• Karnofsky performance status of 70 or higher.

• ≥ 18 years of age

• Life expectancy of ≥ 6 months

• Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0)

• Adequate bone marrow function:

‣ Absolute neutrophil count (ANC) ≥ 1.2 × 10\^9/L without any growth factors in prior 7 days

⁃ Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the prior 14 days

⁃ Platelet count ≥ 75 × 10\^9/L with no platelet transfusion in the prior 7 days

• Adequate hepatic function:

⁃ Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome)

⁃ AST (serum glutamic oxaloacetic transaminase \[SGOT\]) / ALT (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 3 × institutional ULN

• Adequate renal function:

• \- Creatinine clearance per Cockcroft-Gault equation (or institutional equivalent) of ≥ 50 mL/min

⁃ Willingness of patients who are not surgically sterile or with partners who are not postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 90 days after the last dose of study drug.

⁃ Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
North Carolina
Duke University
RECRUITING
Durham
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Syntrix Biosystems Clinical Trials
clinicaltrials@syntrixbio.com
253-833-8009
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 53
Treatments
Experimental: SX-682 + enzalutamide
Related Therapeutic Areas
Sponsors
Leads: Syntrix Biosystems, Inc.
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov