ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (PRESERVE-006)
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| ClinicalTrials.gov Identifier: NCT05682443 |
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Recruitment Status :
Recruiting
First Posted : January 12, 2023
Last Update Posted : April 23, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Drug: ONC-392 Drug: lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses. | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 144 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, open label, active controlled, multi-center study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition |
| Actual Study Start Date : | December 11, 2023 |
| Estimated Primary Completion Date : | June 30, 2026 |
| Estimated Study Completion Date : | June 30, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: ONC-392 plus lutetium Lu 177 vipivotide tetraxetan
Arm A receives ONC-392, IV infusion, for up to 9 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.
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Drug: ONC-392
ONC-392 will be given as IV infusion, Q6W, for up to 9 doses.
Other Names:
Drug: lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses. lutetium Lu 177 vipivotide tetraxetan will be given as IV infusion, Q6W, for up to 6 doses.
Other Name: Pluvicto |
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Active Comparator: lutetium Lu 177 vipivotide tetraxetan
lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.
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Drug: lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.
lutetium Lu 177 vipivotide tetraxetan will be given as IV infusion, Q6W, for up to 6 doses.
Other Name: Pluvicto |
- Radiographic progression free survival (rPFS) [ Time Frame: 24 months ]• To assess the efficacy of ONC-392 plus lutetium Lu 177 vipivotide tetraxetan vs. lutetium Lu 177 vipivotide tetraxetan as assessed by radiographic progression free survival (rPFS). Disease progression was defined by PCWG3 guideline.
- Overall response rate (ORR) [ Time Frame: 24 months ]Objective response rate based on radiographic evaluation of PCWG3.
- TEAE, TRAE and irAE [ Time Frame: 24 months ]Incidence of TEAE, TRAE and irAE.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (≥ 18 years), capable of signing informed consent.
- ECOG score 0 or 1. Life expectancy > 6 months. Adequate organ functions.
- Histologically- or cytologically- confirmed diagnosis of metastatic prostate adenocarcinoma.
- Patients must have a positive PSMA PET/CT scan.
- 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).
- Patients must have received at least one second generation AR-targeting agents (such as enzalutamide and/or abiraterone).
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Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if:
- The patient is not willing to receive a second taxane regimen, or
- The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation or intolerance).
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Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
- 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.
- Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
- Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (PCWG3 criteria).
Patients must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy.
Exclusion Criteria:
- Patients who have not recovered to NCI CTCAE grade≤ 1 from an adverse event (AE) due to prior cancer therapeutics.
- Receiving other anti-cancer agent or device, or participating in other clinical trial, within 28 days of first dose of study treatment.
- 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.
- 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.
- Symptomatic brain metastasis, symptomatic cord compression, or clinical or radiological findings indicative of impending cord compression.
- Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
- Active infections.
- Impaired heart function.
- Active or previously documented autoimmune disease and/or current use of immunosuppressive agents. Use of endocrine replacement therapy (e.g., thyroxine, insulin, low dose of steroid, etc.) is allowed.
- Diagnosed with other malignancies that having ant-cancer treatment within 2 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05682443
| Contact: Pan Zheng, MD, PhD | 8008829960 ext 105 | pzheng@oncoc4.com |
Show 23 study locations
| Principal Investigator: | David Wise, MD | NYU Langone Health | |
| Principal Investigator: | Mark Stein, MD | Columbia University |
| Responsible Party: | OncoC4, Inc. |
| ClinicalTrials.gov Identifier: | NCT05682443 |
| Other Study ID Numbers: |
PRESERVE-006 |
| First Posted: | January 12, 2023 Key Record Dates |
| Last Update Posted: | April 23, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases |
Urogenital Diseases Prostatic Diseases Male Urogenital Diseases 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |