Trial Title:
Study of SX-682 Plus Enzalutamide in Men With Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer
NCT ID:
NCT06228053
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SX-682
Description:
Specified dose twice daily
Arm group label:
SX-682 + enzalutamide
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
Specified dose once daily
Arm group label:
SX-682 + enzalutamide
Other name:
Xtandi
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee
(IEC)-approved informed consent form prior to beginning study and undergoing
procedures.
2. Diagnosis of mCRPC with (a) any histology, (b) measurable disease at enrollment, and
(c) currently on or previously on abiraterone with prednisone 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.
3. 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.
4. Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.
5. Karnofsky performance status of 70 or higher.
6. ≥ 18 years of age
7. Life expectancy of ≥ 6 months
8. Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0)
9. Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1.2 × 109/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 × 109/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
10. 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.
11. Willing and able to provide written informed consent and HIPAA authorization for the
release of personal health information.
Exclusion Criteria:
1. Prior systemic anticancer treatment:
- Prior treatment with docetaxel or marketed antibody within 4 weeks of first
dose of study treatment
- Prior radium-223 therapy within 6 weeks
- Prior PSMA-Lu177-617 therapy within 4 weeks
2. Prior receipt of (a) ketoconazole or any second-generation AR antagonist (e.g.,
enzalutamide, apalutamide, darolutamide), (b) 2 or more chemotherapy regimens with
docetaxel or (c) any chemotherapy other than docetaxel.
3. Current presence of liver metastases on imaging.
4. Has received prior radiotherapy within 2 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis. A 1-week washout is
permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
5. Major surgery requiring general anesthesia within 3 weeks of starting study
treatment (limited biopsy or line placement is acceptable)
6. Has received a live vaccine within 30 days prior to the first dose of study drug.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for
injection are generally killed virus vaccines and are allowed; however, intranasal
influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not
allowed.
7. Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of study intervention.
8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug.
9. Congestive heart failure (New York Heart Association Class III or IV) or unstable
angina pectoris; previous history of myocardial infarction within one year prior to
study entry, uncontrolled hypertension, or uncontrolled arrhythmias.
10. Has a history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.
11. Has known active untreated CNS metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they
are radiologically stable, i.e., without evidence of progression for at least 4
weeks by repeat imaging (note that the repeat imaging should be performed during
study screening), clinically stable and without requirement of steroid treatment
greater than prednisone 10 mg daily (or equivalent) for at least 14 days prior to
first dose of study intervention.
12. Has active autoimmune disease that has required systemic treatment in the past 2
years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
13. Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
14. Has an active infection requiring systemic therapy.
15. Has a known uncontrolled Human Immunodeficiency Virus (HIV) infection based on
detectable HIV viral load and abnormal CD4 count of <350/mm3.
16. Has a known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.
17. Has a known active TB (Bacillus Tuberculosis) infection.
18. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
19. Has known current psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
20. Has had an allogenic tissue/solid organ transplant.
21. Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4,
or (b) QT prolonging as defined in the drug's approved label, with the exception of
drugs that are considered absolutely essential for the care of the subject or if the
Investigator believes that beginning therapy with such medication is vital to an
individual subject's care while on study, and in either case, there is no
alternative drug (if exceptions apply contact Syntrix medical monitor prior to
enrollment).
22. ECG demonstrating a QTc interval > 470 msec or patients with congenital long QT
syndrome.
23. Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina
or congestive heart failure in the last 6 months.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Syntrix Biosystems Clinical Trials
Email:
clinicaltrials@syntrixbio.com
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sweata Kafle
Email:
sweata.kafle@ucsf.edu
Contact backup:
Last name:
Danny Avins
Email:
daniel.avins@ucsf.edu
Investigator:
Last name:
Rahul Aggarwal, MD
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Syntrix Biosystems Clinical Trials
Email:
clinicaltrials@syntrixbio.com
Investigator:
Last name:
Zachery R Reichert, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Syntrix Biosystems Clinical Trials
Email:
clinicaltrials@syntrixbio.com
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Syntrix Biosystems Clinical Trials
Email:
clinicaltrials@syntrixbio.com
Facility:
Name:
University of Wisconsin
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Syntrix Biosystems Clinical Trials
Email:
clinicaltrials@syntrixbio.com
Start date:
June 5, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Syntrix Biosystems, Inc.
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Syntrix Biosystems, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06228053
