Trial Title:
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
NCT ID:
NCT05682443
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, open label, active controlled, multi-center study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONC-392
Description:
ONC-392 will be given as IV infusion, Q6W, for up to 9 doses.
Arm group label:
Arm A: ONC-392 plus lutetium Lu 177 vipivotide tetraxetan
Other name:
A humanized anti-CTLA4 IgG1 monoclonal antibody
Other name:
Gotistobart
Intervention type:
Drug
Intervention name:
lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.
Description:
lutetium Lu 177 vipivotide tetraxetan will be given as IV infusion, Q6W, for up to 6
doses.
Arm group label:
Arm A: ONC-392 plus lutetium Lu 177 vipivotide tetraxetan
Arm group label:
lutetium Lu 177 vipivotide tetraxetan
Other name:
Pluvicto
Summary:
In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior
ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide
tetraxetan, will be enrolled. The study is open-label, randomized with active control,
multi-center study.
Detailed description:
The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in
combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant
prostate cancer patient who have disease progressed on androgen receptor pathway
inhibition. The main questions it aims to answer are (1) whether it is safe to combine
ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases
the radiographic progression free survival (rPFS).
Participants will be randomized to two arms in 2:1 ratio. In experimental arm, they will
be given ONC-392 IV infusion for up to 9 cycles or approximately one year, together with
lutetium Lu 177 vipivotide tetraxetan for up to 6 cycles. In active control arm, they
will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan for
up to 6 cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be ≥ 18 years of age and have the ability to understand and sign an
approved informed consent form (ICF).
2. Patients must have an ECOG performance status of 0 or 1.
3. Patients must have a life expectancy > 6 months.
4. Patients must have histological or cytological confirmation of prostate
adenocarcinoma.
5. Patients must have a positive PSMA in an FDA-approved PSMA PET scan. A positive PSMA
is defined as at least one tumor lesion with PSMA uptake greater than normal liver.
6. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and
a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
7. Patients must have received at least one second generation AR-targeting agents (such
as apalutamide, darolutamide, enzalutamide and/or abiraterone).
8. Patients should have prior treatment of up to two taxane regimens, or are unfit for,
or refuse taxane chemotherapy. A taxane regimen is defined as a minimum exposure of
2 cycles of a taxane. Note: Taxane chemotherapy administered in the Castration
Sensitive Prostate Cancer (CSPC) or Castration Resistant Prostate Cancer (CRPC)
setting is allowed.
9. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on
at least 1 of the following criteria:
1. Serum PSA progression defined as 2 consecutive increases in PSA over a previous
reference value measured at least 1 week prior. The minimal start value is 1.0
ng/mL.
2. RECIST v1.1 soft-tissue progression
3. Progression of bone disease: 2 or more new metastatic bone lesions by bone scan
per PCWG3 criteria.
10. Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or
bone scan imaging obtained ≤ 42 days prior to beginning study therapy.
11. Patients must have adequate organ function.
12. Patients with or without concomitant bisphosphonate or denosumab regimen for ≥ 30
days prior to randomization are eligible.
13. For patients who have partners of childbearing potential: Partner and/or patient
must use adequate methods of birth control with barrier protection, deemed
acceptable by the principal investigator during the study and for 3 months after
last study drug administration.
Exclusion Criteria:
1. Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE)
due to prior cancer therapeutics except neuropathy or endocrinopathy with Gr 2 or
less.
2. Any systemic anti-cancer therapy within 5 half-lives or 14 days, whichever is
shorter (small molecule drugs) or within 28 days for antibody based therapy, prior
to starting study treatment.
3. Known hypersensitivity to the components of the study therapy or its analogs.
4. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or
investigational therapy.
5. Transfusion within 14 days of first day of study treatment
6. PSMA-negative lesions are defined as lesions with PSMA uptake equal to or lower than
that of liver parenchyma. Patients with PSMA-negative lesions in any lymph node with
a short axis of ≥ 2.5 cm, in any metastatic solid-organ lesions with a short axis of
≥ 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of ≥ 1.0 cm
in the short axis are ineligible.
7. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188,
Radium-223 or hemi-body irradiation within 6 months prior to randomization. Previous
PSMA-targeted radioligand therapy is not allowed.
8. Patients with a history of CNS metastases must have received therapy (surgery,
radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not
receiving corticosteroids for the purposes of maintaining neurologic integrity.
Patients with epidural disease, canal disease and prior cord involvement are
eligible if those areas have been treated, are stable, and not neurologically
impaired. For patients with parenchymal CNS metastasis (or a history of CNS
metastasis), baseline and subsequent radiological imaging must include evaluation of
the brain (MRI preferred or CT with contrast).
9. A superscan as seen in the baseline bone scan.
10. Symptomatic cord compression, or clinical or radiologic findings indicative of
impending cord compression.
11. Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, myocardial infarction within 6 months, New York Heart
Association class III or IV congestive heart failure, history of congenital
prolonged QT syndrome, or unstable arrhythmia within 3 months, uncontrolled
infection, active hepatitis B or C, or other significant co-morbid conditions that
in the opinion of the investigator would impair study participation or cooperation.
12. Active concurrent malignancy (with the exception of non-melanomatous skin cancer).
Patients with carcinoma in situ of any origin and patients with prior malignancies
who are in remission and/or whose likelihood of recurrence is very low per
investigator's judgment are eligible for this study.
13. Receiving systemic steroid therapy with > 10 mg/day prednisone or equivalent within
7 days prior to the first dose of study treatment or receiving any other form of
immunosuppressive medication.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California at Davis Cancer Center - 1624
Address:
City:
Davis
Zip:
95817
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Shuchi Gulati, MD
Email:
Principal Investigator
Facility:
Name:
Rocky Mountain Cancer Center USOR - 1633
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Allen Cohn, MD
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Cancer- 1605
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Monica chatwal, MD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University Medical Center - 1627
Address:
City:
Baltimore
Zip:
21202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Channing Paller, MD
Email:
Principal Investigator
Facility:
Name:
Chesapeake Urology Research Associates - 1609
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ronald Tutrone, MD
Email:
Principal Investigator
Facility:
Name:
Lahey Hospital and Medical Center - 1626
Address:
City:
Burlington
Zip:
01805
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Brendan Connell, MD
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center - 1618
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Clark Henegan, MD
Email:
Principal Investigator
Facility:
Name:
XCancer/GU Research Network - 1611
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Luke Nordquist, MD, FACP
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of New Jersey - 1614
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Brian Saraiya, MD
Email:
Principal Investigator
Facility:
Name:
New Mexico Hematology Oncology Assiciates - 1631
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jose Avitia, MD
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center - 1625
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Gurkamal Chatta, MD
Email:
Principal Investigator
Facility:
Name:
NYU Langone Health, Laura & Isaaac Perlmutter Cancer Center - 1601
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Wise, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Columbia University Medical Center - 1602
Address:
City:
New York
Zip:
13302
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mark Stein, MD
Email:
Principal Investigator
Facility:
Name:
University of North Carolina Cancer Center - 1608
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Young Whang, MD
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center - Duke Cancer Center - 1617
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrew Armstrong, MD
Email:
Principal Investigator
Facility:
Name:
The Ohio State University James Cancer Center - 1636
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Lingbin Meng, MD
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University Knight Cancer Institute - 1621
Address:
City:
Portland
Zip:
07239
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alexandra Sokolova, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center - 1604
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Tian Zhang, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists USOR - 1635
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alexander Spira, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Oncology Associates USOR - 1616
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mark Fleming, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Southwest Virginia USOR - 1634
Address:
City:
Norton
Zip:
24273
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Buck, MD
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center (UWCCC) - 1612
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Douglas McNeel, MD, PhD
Email:
Principal Investigator
Start date:
December 11, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
OncoC4, Inc.
Agency class:
Industry
Collaborator:
Agency:
Prostate Cancer Clinical Trials Consortium
Agency class:
Other
Source:
OncoC4, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682443
