Clinical Trials in South Korea / NCT07570979
Recruiting
Phase 1
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
NCT07570979 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Investigational drug(s) / intervention(s)
INR731: Oral administration
Enzalutamide: Oral administration
Abiraterone: Oral administration
Androgen deprivation therapy (ADT): Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
Study summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.
Eligibility
Inclusion Criteria:
* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
* Participants must have histological and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.
* At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to Cycle 1 Day 1 (C1D1).
* Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
* Ongoing androgen deprivation therapy (ADT) either via orchiectomy and/or ongoing gonadotropin-releasing hormone (GnRH) analog or inhibitor is allowed.
* Participants must be mCRPC patients who have either progressed on or are not candidates for other SOC. Prior taxane, poly(ADP) ribose polymerase (PARP) inhibitor, and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) are allowed. Combination expansion patients, however, must be 1L mCRPC with no prior treatment in the mCRPC setting. Treatment within the mHSPC setting does not affect eligibility.
Exclusion Criteria:
* Age \< 18 years old.
* Histological and/or cytological confirmation of non-adenocarcinoma of the prostate.
* Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan) are not eligible.
* Patients previously treated with a cereblon-based degrader.
* Patients who are HIV+ or immune compromised.
* Use of agents known to prolong QT interval unless they can be permanently discontinued for the duration of the study
* Treatment with an investigational agent within 7 days (or 5 half-lives, whichever is longer) of the anticipated Cycle 1 Day 1 (C1D1).
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Incidence and severity of dose-limiting toxicities (DLTs) — 28 days
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 that occurs within the first 28 days and not clearly and incontrovertibly assessed as due to disease progression, intercurrent illness, concomitant medication, or extraneous causes with the exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. - Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to approximately 24 months
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs. - Frequency of dose interruptions and reductions — Up to approximately 24 months
Number of participants with dose interruptions and/or reductions to assess the tolerability. - Dose intensity — Up to approximately 24 months
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Mass General Hospital | Boston | Massachusetts | Recruiting |
| Mary Crowley Cancer Research | Dallas | Texas | Recruiting |
| Novartis Investigative Site | Melbourne | Victoria | Recruiting |
| Novartis Investigative Site | Toronto | Ontario | Recruiting |
| Novartis Investigative Site | Montreal | Quebec | Recruiting |
| Novartis Investigative Site | Dresden | Saxony | Recruiting |
| Novartis Investigative Site | Hirakata | Osaka | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07570979 on ClinicalTrials.gov ↗ ← All trials in South Korea